MAUDE Adverse Event Report: ORTHOFIX SRL PENNIG DYNAMIC WRIST FIXATOR WITH CD UNIT

Model Number 37001

Device Problem Mechanical Problem (1384)

Patient Problem Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

Orthofix (b)(4) would like to communicate that before (b)(6) 2019 no notifications had been received regarding this event occurred in the year 2018.Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the component code 370015 lot v1432003 before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) units.These units were assembled in various batches of pennig fixators code 37000 and code 37001.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific component lot.Technical evaluation: the device involved has been discarded by the hospital and therefore it will not be possible to perform any technical evaluation.Medical evaluation: the information available on the case was sent to our medical evaluator.A preliminary medical evaluation was performed and will be finalized once further details of the event become available.Orthofix (b)(4) has requested further information on the event such as copies of the x-rays of the original fracture preoperatively, immediately postoperative and at all follow up stages, particularly on fixator removal.Unfortunately, up to date, no other information is received.As soon as the results of the investigation are available, orthofix (b)(4) will provide a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.(b)(4).

Event Description

On october 28, 2019, orthofix received an application for damages on behalf of a male patient who was treated for bilateral wrist fractures in (b)(6) 2018.The patient was hit by a car, and 2 days later a pennig wrist fixator was applied to the right wrist on (b)(6) 2018.The left wrist was treated with a different fixation system.15 days after surgery the patient noted a loose fixator screw (not specified).The screw was tightened by the operating surgeon.Patient was seen in the hospital clinic at 30 days; no changes were made to treatment.The patient was admitted for planned fixator removal at 8+ weeks (b)(6).This was done and the fixator (serial number (b)(4)) was thrown away.An x-ray at this time showed "slight dorsalisation of some superior fragments".A complaint is being made because the patient has significant restriction of normal movement which is considered to be due to malfunction of the fixator.On november 18, 2019, orthofix was confirmed that the fixator involved is not available for the investigation.Manufacturer reference number: (b)(4).

Event Description

On october 28, 2019.Orthofix received an application for damages on behalf of a male patient who was treated for bilateral wrist fractures on (b)(6) 2018.The patient was hit by a car, and 2 days later a pennig wrist fixator was applied to the right wrist on (b)(6) 2018.The left wrist was treated with a different fixation system.15 days after surgery the patient noted a loose fixator screw (not specified).The screw was tightened by the operating surgeon.Patient was seen in the (b)(6) clinic at 30 days; no changes were made to treatment.The patient was admitted for planned fixator removal at 8+ weeks on (b)(6).This was done and the fixator (serial number: (b)(6) was thrown away.An x-ray at this time showed "slight dorsalisation of some superior fragments".A complaint is being made because the patient has significant restriction of normal movement which is considered to be due to malfunction of the fixator.On (b)(6) 2019, orthofix was confirmed that the fixator involved is not available for the investigation.On (b)(6) 2019, orthofix srl received information that the device used was found and will be returned to orthofix.It seems that the x-rays will not be made available.Manufacturer reference number: (b)(4).

Manufacturer Narrative

Orthofix srl would like to communicate that before october 28, 2019 no notifications had been received regarding this event occurred in the year 2018.Analysis of historical records: orthofix srl checked the internal records related to the controls made on the fixator code: 37001, lot: b1200518 (lot laser marked on the component code: 370015 is: (b)(6) before the market release.No anomalies have been found.The original lot, manufactured in 2017, was comprised of (b)(4) units.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot.Technical evaluation: the returned device, received on november 27, 2019, was examined by orthofix quality engineering department.The device was disassembled and all the components were subjected to visual, dimensional and functional check.The visual check evidenced presence of damaging signs on all surfaces of the device/components, due to wear.The dimensional check did not evidence any anomalies, apart the dimension slightly undersized of the damaged spherical parts of the pennig joint (component code: 37030).The functional check did not evidence any issues.The results of the technical evaluation evidenced that the returned fixator was originally conforming to orthofix specification.The dimensional anomaly detected is attributable to the wear damage found on the surface of the two spherical parts of the joint.However, the functional check did not evidence any anomalies.The static test was not performed to avoid potential further damage of the fixator, as specifically requested by the legal department.Medical evaluation: the information available on the case together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluation performed.November 17, 2019 with the initial information: "orthofix have just received an application for damages on behalf of a male patient, who was treated for bilateral wrist fractures on (b)(6) 2018.The patient was hit by a car, and 2 days later a pennig wrist fixator was applied to the right wrist on (b)(6).The left wrist was treated with a different fixation system.15 days after surgery the patient noted a loose fixator screw (not specified).The screw was tightened by the operating surgeon.Patient was seen in the (b)(6) clinic at 30 days; no changes were made to treatment.The patient was admitted for planned fixator removal at 8+ weeks on (b)(6).This was done and the fixator (serial number: (b)(6) was thrown away.An x-ray at this time showed "slight dorsalisation of some superior fragments".A complaint is being made because the patient has significant restriction of normal movement which is considered to be due to malfunction of the fixator.My view is that in the worst case this patient has suffered a degree of permanent disability as a result of the fracture.However the cause of this is completely unestablished: the fixator itself has been discarded by the hospital, so tests of its functionality are impossible we have no record of the fracture treatment beyond the facts stated above we need x-rays of the original fracture preoperatively, immediately postoperative and at all follow up stages, particularly on fixator removal.We know that this fixator performs well and have no record of malfunction in the other fixators sold of this type.I cannot read the operative notes to determine that the screws were tightened originally.We know that some fractures of the distal radius can be very hard to reduce into a good position without some additional internal fixation, especially if comminuted.We also know that this injury was the result of a collision with a car as a result of which both wrists were broken; it was therefore a high energy injury and the x-ray report states that it was 'multi-fragmentary'.I think that it is highly likely that this alleged poor result was due to the severity of the original injury, and failure of the treatment to reduce and hold the fragments in a correct position.We must have the x-rays to make any judgement of the sequence of events.We do not know why this treatment ended in a poor result.Fixator screws do not normally come loose at 3 weeks if they have been tightened correctly.Further comments are impossible without more information".January 13, 2020 with the results of the technical evaluation performed on the returned device: "the technical report on this fixator shows that it has been used before, because one of the ball-joint bushes is significantly worn.It has not been fully tested mechanically because this might damage it.The 2 joints were tested for tolerances and are out of the correct range of values.They were originally within range when supplied.The referral letter states that a screw became loose some time after the fixator was applied.However, we have no idea which screw this might have been, and what effect it might have had on the patient.So, although the fixator has not been tested to failure, the indications are that it has been used before, with some worn dimensions on the ball joints, but that it remains within specification for performance.We know from a large experience of these fixators that none of the screws or cams become loose after fixator application until fixator removal, provided that they are tightened correctly when the fixator is applied as specified in the operating manual.I must therefore agree with the conclusions of the technical report that the premature loosening of a screw or cam during the application in subject was not device related.We have no further information about the treatment or this event in spite of repeated requests for more details, and can therefore make no further comment".Conclusion: orthofix srl would like to communicate that before october 28, 2019 no notifications had been received regarding this event occurred in the year 2018.The results of the technical evaluation evidenced that the returned fixator was originally conforming to orthofix specification.The dimensional anomaly detected is attributable to the wear damage found on the surface of the two spherical parts of the joint.However, the functional check did not evidence any anomalies.The static test was not performed to avoid potential further damage of the fixator, as specifically requested by the legal department.The static test will be performed on demand.The medical evaluation evidenced as follows: november 17, 2019 with the initial information: "orthofix have just received an application for damages on behalf of a male patient, who was treated for bilateral wrist fractures on (b)(6) 2018.The patient was hit by a car, and 2 days later a pennig wrist fixator was applied to the right wrist on (b)(6).The left wrist was treated with a different fixation system.15 days after surgery the patient noted a loose fixator screw (not specified).The screw was tightened by the operating surgeon.Patient was seen in the (b)(6) clinic at 30 days; no changes were made to treatment.The patient was admitted for planned fixator removal at 8+ weeks on (b)(6).This was done and the fixator (serial number: (b)(6) was thrown away.An x-ray at this time showed "slight dorsalisation of some superior fragments".A complaint is being made because the patient has significant restriction of normal movement which is considered to be due to malfunction of the fixator.My view is that in the worst case this patient has suffered a degree of permanent disability as a result of the fracture.However the cause of this is completely unestablished: the fixator itself has been discarded by the hospital, so tests of its functionality are impossible.We have no record of the fracture treatment beyond the facts stated above we need x-rays of the original fracture preoperatively, immediately postoperative and at all follow up stages, particularly on fixator removal.We know that this fixator performs well and have no record of malfunction in the other fixators sold of this type.I cannot read the operative notes to determine that the screws were tightened originally.We know that some fractures of the distal radius can be very hard to reduce into a good position without some additional internal fixation, especially if comminuted.We also know that this injury was the result of a collision with a car as a result of which both wrists were broken; it was therefore a high energy injury and the x-ray report states that it was 'multi-fragmentary'.I think that it is highly likely that this alleged poor result was due to the severity of the original injury, and failure of the treatment to reduce and hold the fragments in a correct position.We must have the x-rays to make any judgement of the sequence of events.We do not know why this treatment ended in a poor result.Fixator screws do not normally come loose at 3 weeks if they have been tightened correctly.Further comments are impossible without more information".January 13, 2020 with the results of the technical evaluation performed on the returned device: "the technical report on this fixator shows that it has been used before, because one of the ball-joint bushes is significantly worn.It has not been fully tested mechanically because this might damage it.The 2 joints were tested for tolerances and are out of the correct range of values.They were originally within range when supplied.The referral letter states that a screw became loose some time after the fixator was applied.However, we have no idea which screw this might have been, and what effect it might have had on the patient.So, although the fixator has not been tested to failure, the indications are that it has been used before, with some worn dimensions on the ball joints, but that it remains within specification for performance.We know from a large experience of these fixators that none of the screws or cams become loose after fixator application until fixator removal, provided that they are tightened correctly when the fixator is applied as specified in the operating manual.I must therefore agree with the conclusions of the technical report that the premature loosening of a screw or cam during the application in subject was not device related.We have no further information about the treatment or this event in spite of repeated requests for more details, and can therefore make no further comment".Orthofix srl requested further information on the event such as copies of the x-rays of the original fracture preoperatively, immediately postoperative and at all follow up stages, particularly on fixator removal.Unfortunately, no other information was made available.Based on the results of the technical evaluation, which confirmed the device originally conformity to specification, and on the evidences deriving from the medical evaluation, orthofix can conclude that the problem that occurred is not device related.Should further details become available, orthofix srl will finalize the investigation and provide a follow up report.Orthofix historical records shows that no other notifications have been received in regards to this specific device lot.Orthofix srl continues monitoring the devices on the market.

• Brand Name: PENNIG DYNAMIC WRIST FIXATOR WITH CD UNIT
• Type of Device: PENNIG DYNAMIC WRIST FIXATOR WITH CD UNIT
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 9352704
• MDR Text Key: 185270059
• Report Number: 9680825-2019-00077
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• PMA/PMN Number: K955848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 37001
• Device Catalogue Number: 37001
• Device Lot Number: B1200518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR