MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN 100 W/GRIPTION 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-31-050
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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
A complaint from a customers was received where the inserter was jammed to the pinnacle cup after insertion of the cup.Outcome was that the cup had to be removed and replaced with a new one.The inserter jammed in the cup.The cup had to be removed.The cup is still connected to the inserter.Occurred during surgery.Surgical delay of 15 minutes.

• Brand Name: PINN 100 W/GRIPTION 50MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11300450
• Report Number: 1818910-2021-02649
• Device Sequence Number: 16329039
• Product Code: KWA
• UDI-Device Identifier: 10603295010197
• UDI-Public: 10603295010197
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K090998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2020

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: 1217-31-050
• Device Catalogue Number: 121731050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1