MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFCSIGMA STAB+INSTRL17.5MMS2.5; KNEE INSTRUMENT : TIBIAL TRIALS

Model Number	96-2823
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
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.The device associated with this report was returned for analysis.After physical review of the part, allegation was not confirmed since device is not cracked but broken.It was observed that the rim on the underside was separated from the rest of the part.Separated part was not returned for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Event or Problem Description
The rim of the underside of the 17.5 mm size 2.5 tibial insert trial fractured.It remained in one piece.
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.The device associated with this report was returned for analysis.After physical review of the part, allegation was not confirmed since device is not cracked but broken.It was observed that the rim on the underside was separated from the rest of the part.Separated part was not returned for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Event or Problem Description
The rim of the underside of the 17.5 mm size 2.5 tibial insert trial fractured.It remained in one piece.

• Brand Name: PFCSIGMA STAB+INSTRL17.5MMS2.5
• Common Device Name: KNEE INSTRUMENT : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13265778
• Report Number: 1818910-2022-00932
• Device Sequence Number: 3207918
• Product Code: HWT
• UDI-Device Identifier: 10603295244707
• UDI-Public: 10603295244707
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2022

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: 96-2823
• Device Catalogue Number: 962823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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