MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM LCP® CURVED CONDYLAR PLATE 10 HOLES/242MM-LEFT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	02.001.300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Additional 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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that patient underwent revision surgery on (b)(6) 2023, due to a broken plate.Patient was stable during surgery and postoperatively.This report is for a 4.5mm lcp® curved condylar plate 10 holes/242mm-left.This is report 1 of 1 for (b)(4).
Additional 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.D10 concomitant therapy date (b)(6) 2023.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
Additional 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.H11 additional narrative: h3, h6: part number: 02.001m300sp lot number: 335p495 part manufacturing date: 19-aug-2021 manufacturing site: elmira part expiration date: n/a nonconformance noted: n/a a review of the device history record revealed no complaint-related anomalies.The device history record shows lot 355p495 of 4.5 mm lcp curved condylar plates was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the component device history record(s) determined the component lot 57p7560 met all specifications with no issues documented that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot h765273 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint-related anomalies.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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 4.5 lcp crvd cond pl 10 holes/242-lft was found broken across to one of the locking holes, scratches were observed in the fracture.Both fragments were received for evaluation.A dimensional inspection for the va-lcp condylar plate 4.5/5.0 r 12ho l26 was not performed due to post manufacturing damage.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 va-lcp condylar plate 4.5/5.0 r 12ho l26 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: 4.5MM LCP® CURVED CONDYLAR PLATE 10 HOLES/242MM-LEFT
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14846
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18476519
• Report Number: 8030965-2024-00486
• Device Sequence Number: 20568929
• Product Code: KTT
• UDI-Device Identifier: 10886982027535
• UDI-Public: (01)10886982027535
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K041911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02.001.300
• Device Lot Number: 335P495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 02/06/2024; 06/25/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/16/2024; 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.5 LCP CRVD COND PL 10 HOLES/242-LFT; CANN-LOCKSCR Ø5 L65 SST; CANN-LOCKSCR Ø5 L70 SST; CANN-LOCKSCR Ø5 L75 SST; LOCKSCR Ø5 SELF-TAP L55 SST; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; X10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 86 KG