MAUDE Adverse Event Report: SYNTHES GMBH 4.5 VA-LCP CURVED COND PL/18 HOLE/370/RT; CONDYLAR PLATE FIXATION IMPLANT

Model Number 02.124.418

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, during intra-op while attaching the percutaneous aiming arm on the va-lcp curved condylar plating system, the va hole that attaches to the aiming arm stripped.The plate was unable to be used.A plate one size in length was used and able to complete the surgery.There was no patient consequences.It was unknown if there was any surgical delay, or any fragments were generated or if the surgery was successfully completed.This complaint involves one (1) device.This report is for one (1) 4.5 va-lcp curved cond pl/18 hole/370/rt.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Additional pro-code: hwc, hrs 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial, a follow-up will be filed as appropriate.

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, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

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.A manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.Product code: 02.124.418, lot number: 553p563, manufacturing site: mezzovico, release to warehouse date: 21 dec 2021.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 inner threads of the 4.5 va-lcp curved cond pl/18 hole/370/rt that pair with the interlocking bolt were slightly stripped.No other defect was found.A dimensional inspection 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/18 hole/370/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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5 VA-LCP CURVED COND PL/18 HOLE/370/RT
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16284966
• MDR Text Key: 308673357
• Report Number: 8030965-2023-01311
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042972
• UDI-Public: (01)10886982042972
• 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: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.418
• Device Catalogue Number: 02.124.418
• Device Lot Number: 553P563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - GUIDES/SLEEVES/AIMING: GUIDE
• Patient Age: 93 YR
• Patient Sex: Male