MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5 VA-LCP CURVED COND PL/12 HOLE/266/RT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.124.412

Device Problem Fitting Problem (2183)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: date of event is unknown.It is unknown when implants were originally implanted and it is unknown when the devices backed out.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.No code available for injury due to revision surgery.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that distal femur open reduction internal fixation revision occurred on (b)(6) 2022 due to multiple 5.0mm va locking screws backing out of plate.It is unknown when the original surgery occurred.During the revision the surgeon attempted to re-tighten the same screw back into the plate with a screwdriver and appropriate 6nm toque limiting t handle.The re-tightening of the screws did not work as the screw heads were not locking into the plate.Upon removal and inspection of the original 12h variable angle curved condylar plate, it was noted by surgeon that the screw holes of the plate and the locking threads on the 5.0mm variable angle locking screws were compromised.He had to place a new plate and screws in the patient as a correction for the original surgery.No surgery delayed and the procedure successfully completed.This is report 1 of 6 for (b)(4).This report is for a condylar plate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: product code: 02.124.412.Lot no: 278p591.Manufacturing site: (b)(4).Release to warehouse date: july 24, 2021.A manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the 4.5 va-lcp curved cond pl/12 hole/266/rt was found the worn on the thread hole.This can be related to the condition of not locking.A dimensional inspection for the 4.5 va-lcp curved cond pl/12 hole/266/rt was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 4.5 va-lcp curved cond pl/12 hole/266/rt would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5 VA-LCP CURVED COND PL/12 HOLE/266/RT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14110920
• MDR Text Key: 289254106
• Report Number: 2939274-2022-01292
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042859
• UDI-Public: (01)10886982042859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.412
• Device Catalogue Number: 02.124.412
• Device Lot Number: 278P591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.0 VA LCK SCRW/S/TAP /55.; 5.0 VA LCK SCRW/S/TAP /70.; 5.0 VA LCK SCRW/S/TAP /80.; 5.0 VA LCK SCRW/S/TAP /85.; 5.0 VA LCK SCRW/S/TAP /90.; UNK - SCREWDRIVERS.; UNK - TORQUE DEVICES.
• Patient Outcome(s): Required Intervention