MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFCSIG OV/DOMPAT 3PEG TRL38MM; KNEE INSTRUMENT : PATELLA TRIALS

Model Number	96-1102
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Broken due to fair wear and tear.Email response - what part of the pfcsig ov/dompat 3peg trl38mm broke?one of the pegs did it break into two or more pieces? if no, please specify what is the alleged deficiency of the instrument.Is it bent, cracked, stripped or cross threaded? peg broke off.Please provide valid lot number for pfcsig ov/dompat 3peg trl38mm (961102).Unavailable please verify if the instrument was used during surgery? if yes, was there surgical delay? yes and yes.What was the duration of the delay? 5 mins whilst they opened another patella instrument tray.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: PFCSIG OV/DOMPAT 3PEG TRL38MM
• Common Device Name: KNEE INSTRUMENT : PATELLA 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: kara ditty-bovard ; 1210 ward av; west chester, PA 19380 ; 6107428552
• MDR Report Key: 13109070
• Report Number: 1818910-2021-28925
• Device Sequence Number: 11587070
• Product Code: HWT
• UDI-Device Identifier: 10603295234890
• UDI-Public: 10603295234890
• 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: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Model Number: 96-1102
• Device Catalogue Number: 961102
• 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: 12/14/2021
• Supplement Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 01/03/2022
• 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