MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PFCSIGMA POST FEMAUG TRL4MM S4; KNEE INSTRUMENT : ALIGNMENT DEVICES

Catalog Number	961886
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the size 4 4mm posterior augment trial no longer snaps on to the femur trial.There was no surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = according to the information received, ¿it was reported that the size 4 4mm posterior augment trial no longer snaps on to the femur trial.There was no surgical delay".The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that the post of the pfcsigma post femaug trl4mm s4 has broken off, fragment was not returned for evaluation.Additionally, the device shows an overall worn appearance consistent with normal and repetitive use over a long period of time.Based on the damage of the post it is reasonable that the observed condition prevents the device from holding and/or assembling the femur trial as intended.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing for over 27 years old.The overall complaint was confirmed as the observed condition of the pfcsigma post femaug trl4mm s4 would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (d0996) provided is not a valid finished goods lot# h3.

• Brand Name: PFCSIGMA POST FEMAUG TRL4MM S4
• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17683440
• Report Number: 1818910-2023-18075
• Device Sequence Number: 12306943
• Product Code: HWT
• UDI-Device Identifier: 10603295240396
• UDI-Public: 10603295240396
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 961886
• Device Lot Number: D0996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 09/26/2023; 10/02/2023; 10/03/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 09/27/2023; 10/03/2023; 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/1996
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female