MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFCSIG POSTLIP TRIAL 10MM SZ4; TIBIAL INSERT TRIALS

Catalog Number	961251
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that trial liner was damaged.Was the product being used in a clinical trial? no.Did the event happen during a procedure? no.Were you in the procedure at the time of the event? no.Event outcome/how was it managed? n/a.Was there any consequence to the patient due to complaint? no.Was the surgery prolonged due to the event? if yes, confirm how many minutes delay: no.Has the reporter facility indicated there may be legal action? no.Damaged trial liner.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary according to the information received, damaged trial liner.The product was not returned to depuy synthes, however photo was provided for review.See attachment (b)(4) - ppg broken insert 4 10mm pfc.The photo investigation revealed that device 961251, pfcsig postlip trial 10mm sz4 had surface worn out, broken condition can be seen at right side from the provided evidence.Based on the available evidence, a definitive root cause could not be determined.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 961251, pfcsig postlip trial 10mm sz4 would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.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 the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.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.

• Brand Name: PFCSIG POSTLIP TRIAL 10MM SZ4
• Common Device Name: TIBIAL INSERT TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18552459
• Report Number: 1818910-2024-01515
• Device Sequence Number: 6402838
• Product Code: HWT
• UDI-Device Identifier: 10603295236382
• UDI-Public: 10603295236382
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2024

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: 961251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown