MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFCSIG POSTLIP TRIAL 10MM SZ3; KNEE INSTRUMENT

Catalog Number	961241
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
Dan did a pfc today- during the case small pieces came off the above insert- please can you send us a replacement trial insert.Flossy also mentioned that one of our sets is also missing a black patella trial.
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: product complaint # (b)(4).Investigation summary: conclusion and justification status: the complaint states (b)(6) did a pfc today- during the case small pieces came off the above insert- please can you send us a replacement trial insert.The device was reviewed by bioengineering and a report was received stating; the arc indents appear to have been made by the drill guide holes on the femoral trial component.However there is not enough information to confirm this assumption.The cause of the markings on the edge is undetermined due to lack of information.However they should not be there through normal use of the tibial insert trial.The scratches that can be seen on the condyles of the trial insert are most likely caused due to debris in the joint space.However there is not enough information to confirm this.Conclusion: the root cause of this complaint is undetermined due to lack of information.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per sep 419.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
There is no new information to report at this time.Per fda request, this follow-up is being submitted to fill the gap in follow-up sequence numbers.

• Brand Name: PFCSIG POSTLIP TRIAL 10MM SZ3
• Common Device Name: KNEE INSTRUMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7117386
• Report Number: 1818910-2017-51688
• Device Sequence Number: 16433171
• Product Code: LXH
• UDI-Device Identifier: 10603295236252
• UDI-Public: 10603295236252
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

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: 961241
• Device Lot Number: TP412693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 04/24/2025
• Date Device Manufactured: 08/04/2017
• 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