MAUDE Adverse Event Report: ORTHOFIX SRL ADV RING HINGE

Model Number 53570

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 11/24/2017

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records orthofix (b)(4) checked the internal records related to the controls made on the device code 53570 batch b1199632 (lot f73 laser marked on component 530570) before the market release.No anomalies have been found.The original lot, manufactured in 2017, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first notification received from this specific device lot.Technical evaluation the returned device, received on january 4, 2018 was examined by orthofix (b)(4) quality engineering department.The two components of the device, code ref.500528 compression/distraction body and code ref.530570 joint were subjected to visual and dimensional check as per orthofix (b)(4) design and product specifications.Item code 530570 joint.The visual check did not evidence any anomalies.The dimensional check confirmed that the item is in conformity with orthofix (b)(4) specifications.The functional check confirmed that the item is still performing properly.Item code 500528 compression/distraction body.The visual check performed on item 500528, evidenced that the thread is damaged and that the threaded rod is blocked.It was not possible to perform the dimensional check as the thread is blocked.The functional check evidenced that the component is not functioning properly.The threaded rod of the body is blocked.We may suppose that the damage of the thread led to blocking of the compression/distraction unit.Medical evaluation the information made available on the case together with the results of the technical investigation, was sent to our medical evaluator.Please find below an extract of the medical evaluations: on 22 january 2018 the information provided for the assessment of this event is very minimal and insufficient for us to make any sensible comment.The complaint is that distraction was not possible when using the lrs adv ring hinge (53570).No other information is provided.On 25 january 2018 with the outcome of the technical analysis.It seems clear that no further information will become available about this event.Absolutely no data are available about the patient.All we are told is that the device was replaced on the next day in the doctors office (i.E.No further surgery was required).The last box in the report form about the patient's current condition simply states "ok", so we must assume that the patient is well.The technical analysis makes it clear that: 1.The ring hinge itself is completely to specification and functions normally.2.The compression-distraction unit which is part of the device code is blocked because the thread is distorted.It is not clear when or why this happened.Because the device is locked it is not possible to turn the hexagon to produce distraction.A section of the visible thread on the device is badly distorted.I think now that when the reported of this event wrote "distraction is not possible", he meant that the cd unit is blocked and therefore the device is not usable.He was not talking about lengthening.My confusion about this is entirely due to the very poor reporting of this incident with no facts except the comment noted above.We do not know why the cd unit is locked, but i note that the whole device is single use only.Also according to the quality checks this device was functioning normally when it was released to the market.So the conclusion must be that the compression-distraction unit belonging to this device had become damaged somehow between the manufacture of the device and the use on this patient.Final comments the results of the technical evaluation evidenced that the device was originally conforming to orthofix (b)(4) design specifications.Component code 530570, joint, is still performing properly.Component code 500528, compression/distraction body, is not functioning properly.We may suppose that the damage of the thread led to the blocking of the compression/distraction unit.The medical evaluation evidenced as follows: the complaint is that distraction was not possible when using the lrs adv ring hinge (53570).No other information is provided.We do not know why the cd unit is locked, but i note that the whole device is single use only.Also according to the quality checks this device was functioning normally when it was released to the market.So the conclusion must be that the compression-distraction unit belonging to this device had become damaged somehow between the manufacture of the device and the use on this patient.The results of the technical evaluation concluded that the returned device was originally conforming to orthofix (b)(4) design specifications.The failure occurred could be related to the damage of the thread that led to the blocking of the compression/distraction unit.The analysis of the historical data evidenced that no other similar notifications have been received on devices belonging to the same lot.Orthofix (b)(4) continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: hospital name: (b)(6) hospital, surgeon's name: dr.(b)(6), date of surgery: (b)(6) 2017, body part to which device was applied: na, surgery description: fracture treatment, patient information: not provided, problem observed during: clinical use on patient/intraoperative, type of problem: device functional problem, event description: distraction was not possible.The complaint report form also indicates: the device failure had adverse effects on patient: loss of distraction/correction achieved.The surgery was not completed with the device.A replacement device was used to complete surgery, the next day.The event led to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was not required.Copies of the operative reports are not available.Copies of the x-ray images are not available.Patient current health condition: o.K.Further information received from the distributor on january 24, 2018: no patient's data is available.The affected device was replaced the day after the initial surgery ((b)(6) 2017) in the doctor office.No additional surgery was required.It was indicated an increase in the surgical procedure as the replacement device was attached next day no copies of the operative report and copies of the pre and post-operative x-rays are available.(b)(4).

• Brand Name: ADV RING HINGE
• Type of Device: ADV RING HINGE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer Contact: roberto donadello ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 7230355
• MDR Text Key: 98698170
• Report Number: 9680825-2018-00005
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K955848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 53570
• Device Catalogue Number: 53570
• Device Lot Number: B1199632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention