MAUDE Adverse Event Report: ORTHOFIX SRL ADV MULTIPLANAR CLAMP

Model Number 53581

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Technical evaluation the device involved in this event has not been received yet at orthofix srl.The technical evaluation will be performed as soon as the device is returned.Medical evaluation the information made available on the case was sent to our medical evaluator.A preliminary medical evaluation was performed and will be finalized once the results of the technical evaluation are available.As soon as the results of the investigation become available, orthofix srl will provide you with a follow up report.Orthofix srl continues monitoring the devices on the market.

Event Description

The information initially provided by the local distributor indicates: product code: 53581, lot unknown.Hospital name: (b)(6).Surgeon's name: dr.(b)(6).Date of initial surgery: unknown.Body part to which device was applied: left femoral.Surgery description: correction.Patient information: unknown.Problem observed during: into treatment/postoperative.Type of problem: device functional problem.Event description: "the part that controls the rotation of the multi-planar was broken during treatment.A modular type external fixator is used as an alternative.The product has not been returned and detailed information including lot number is still unknown." the complaint report form also indicates: the device failure had adverse effects on patient.The initial surgery was not completed with the device.A replacement device of the same model was not immediately available to complete.Surgery: the modular type external fixator was used to complete surgery.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was not required.A medical intervention (outpatient clinic) was required: we have not any information yet, except that the modular fixator was used as an alternative.Copies of the operative reports are not available.Copies of the x-ray images are not available.Patient current health condition: there is no problem with the patient's condition.Further information received on july 16, 2020 from the local distributor: the device was only replaced and no additional surgery was performed.(b)(4).

Manufacturer Narrative

Technical evaluation: the device involved in this event was received at orthofix srl on august 17, 2020.The technical evaluation is in progress.Medical evaluation: the information made available on the case was sent to our medical evaluator.A preliminary medical evaluation was performed and will be finalized once the results of the technical evaluation are available.As soon as the results of the investigation become available, orthofix srl will provide you with a follow up report.Orthofix srl continues monitoring the devices on the market.

Event Description

The information initially provided by the local distributor indicates: - product code: 53581, lot unknown.- hospital name: (b)(6) general hospital.- surgeon's name: dr.(b)(6).- date of initial surgery: unknown.- body part to which device was applied: left femoral.- surgery description: correction.- patient information: unknown.- problem observed during: into treatment/postoperative.- type of problem: device functional problem.- event description: "the part that controls the rotation of the multi-planar was broken during treatment.A modular type external fixator is used as an alternative.The product has not been returned and detailed information including lot number is still unknown." the complaint report form also indicates: - the device failure had adverse effects on patient.- the initial surgery was not completed with the device.- a replacement device of the same model was not immediately available to complete surgery: the modular type external fixator was used to complete surgery.- the event did not lead to a clinically relevant increase in the duration of the surgical procedure.- an additional surgery was not required.- a medical intervention (outpatient clinic) was required: we have not any information.Yet, except that the modular fixator was used as an alternative.- copies of the operative reports are not available.- copies of the x-ray images are not available.- patient current health condition: there is no problem with the patient's condition.Further information received on july 16, 2020 from the local distributor: the device was only replaced and no additional surgery was performed.Further information received on july 27, 2020 from the local distributor: patient information: 51 year old male, height 178 cm, weight 80 kg.First surgery date: (b)(6) 2019.Lrs broken date: (b)(6) 2020.Lrs exchange date: july 2, 2020.The exchange of the lrs fixator was performed under general anesthesia.The surgeon struck the bone, crushed it, shortened it, and then re-installed the lrs.Was the treatment for an angular deformation? yes, it was the angular deformity of the proximal femur.When the device broke, was the correction already finalized? unknown was the alternative modular fixator used temporarily or until consolidation? unknown manufacturer ref: 2020104.Distributor ref: (b)(4).

Manufacturer Narrative

Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code 53581 (lot b05 laser marked on component 530598 connection multiplanar rail) before the market release.No anomalies have been found.The original lot was manufactured between year 2015 (60 units) and year 2017 (59 units).117 of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received for this specific device lot.Technical evaluation: the returned device, received on 17th august 2020, was examined by orthofix srl quality engineering department.The device was subjected to visual check as per orthofix srl specifications.The visual check confirmed that the device component code 530598 is broken and the clamp has scratches and signs of damage.The broken device was then sent to an external laboratory to verify the material conformity and for further investigation.Please find below an extract of the technical evaluation received: the analyzed component is made from wrought aluminum-zinc-magnesium alloy (en aw-7075).The microstructure is characterized by the presence of numerous intermetallic precipitates.Hardness measured values (162 hbw) is coherent with an aging treatment t6, which maximize the mechanical characteristics.The fracture surface features a small area of fatigue fracture propagation followed by a brittle fracture of the remaining section.In particular the fracture analysis shows presence of different small propagation fronts which coalesced afterward in a single large propagation front up to the complete failure.The verification of the raw material performed by an external laboratory confirmed that the material is conforming to orthofix srl specifications.The orthofix srl technical team confirms that based on the information available the breakage is fully attributable to fatigue failure due to extensive use of the device.Medical evaluation: the information made available on the event together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluations performed.23rd july 2020 the use of the multiplanar adv clamp is described on pages 33 to 36 of the lrs adv operative technique.It is very important that the cora is aligned correctly with the clamp hinge so that undue tension does not result in the clamp.It is not clear from the small amount of information supplied why the clamp broke on this occasion.All we are told is that the part that controls rotation broke.We need x-rays and to understand how the procedure was planned.It is likely that the circumstances of its application led to excessive loading of the fixator clamp, but we have no way of knowing this at present.We are told that the treatment continued.We are not told what type of fixator was used for the final phase of treatment.30th september 2020 with the results of the technical analysis as you say we have now received additional information on this case.This information is very useful: lrs broken date: (b)(6), 2020 date of original surgery was not provided, but the patient was being treated for an angular deformity of the femur; this is the date that the clamp broke lrs exchange date: (b)(6) 2020 the word 'exchange' is critical.The broken multiplanar clamp was exchanged for a new one, and correction continued.The exchange of the lrs fixator was performed under general anesthesia.The surgeon struck the bone, crushed it, shortened it, and then re-installed the lrs.The surgeon exposed the new callus and shortened it by pushing the material down so that a new multiplanar clamp could be attached to the bone screws at the same angle.To me this is the only interpretation.We must presume that the correction then continued.The angular deformity was almost certainly a varus, as shown on page 35 of the lrs-adv operative technique.The last 2 sentences of the 2nd paragraph describe the steps.The surgeon must lengthen first with the deformity unaltered, and then shorten and make the correction at the same time.If the surgeon tries to make the angular correction after the osteotomy but before lengthening, the soft tissue tension will be very great and may well be what happened in this case.This multiplanar clamp broke at the swivel joint between the clamp body and the clamp that fits on the end of the rail.This is the weakest point of the fixator when it is subject to bending loads.We are told in the technical analysis that this clamp failed because of fatigue, and as a result of wear and tear, or repeated use.It seems that the patients was treated with a new lrs unit and presumably completed treatment (but we do not know this).Final comments: the results of the technical evaluation concluded that the returned device was originally conforming to orthofix specifications.According to the information provided on the case and as a result of the investigation performed, orthofix srl can conclude that the failure is attributable to the application of excessive fatigue load on the device.Since the original lot of this device was manufactured between year 2015 (60 units) and year 2017 (59 units) we may also assume that it was subjected to multiple uses.The analysis of the historical data evidenced that no other notifications have been received on devices belonging to the same lot.Orthofix continues monitoring the products on the market.

Event Description

The information initially provided by the local distributor indicates: product code: 53581, lot unknown.Hospital name: (b)(6).Surgeon's name: (b)(6).Date of initial surgery: unknown.Body part to which device was applied: left femoral.Surgery description: correction.Patient information: unknown.Problem observed during: into treatment/postoperative.Type of problem: device functional problem.Event description: "the part that controls the rotation of the multi-planar was broken during treatment.A modular type external fixator is used as an alternative.The product has not been returned and detailed information including lot number is still unknown." the complaint report form also indicates: the device failure had adverse effects on patient.The initial surgery was not completed with the device.A replacement device of the same model was not immediately available to complete surgery: the modular type external fixator was used to complete surgery.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was not required.A medical intervention (outpatient clinic) was required: we have not any information yet, except that the modular fixator was used as an alternative.Copies of the operative reports are not available.Copies of the x-ray images are not available.Patient current health condition: there is no problem with the patient's condition.Further information received on (b)(6), 2020 from the local distributor: the device was only replaced and no additional surgery was performed.Further information received on (b)(6), 2020 from the local distributor: patient information: 51 year old male, height 178 cm, weight 80 kg first surgery date: (b)(6), 2019 lrs broken date: (b)(6), 2020 lrs exchange date: (b)(6), 2020 the exchange of the lrs fixator was performed under general anesthesia.The surgeon struck the bone, crushed it, shortened it, and then re-installed the lrs.Was the treatment for an angular deformation? yes, it was the angular deformity of the proximal femur.When the device broke, was the correction already finalized? unknown was the alternative modular fixator used temporarily or until consolidation? unknown manufacturer ref: (b)(4).Distributor ref: (b)(4).

• Brand Name: ADV MULTIPLANAR CLAMP
• Type of Device: ADV MULTIPLANAR CLAMP
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 10307196
• MDR Text Key: 208130921
• Report Number: 9680825-2020-00042
• 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: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 53581
• Device Catalogue Number: 53581
• Device Lot Number: B05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Date Manufacturer Received: 09/24/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 80