MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 60MM GRIPPER; HIP INSTRUMENT/TRIAL

Model Number	2218-90-060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	08/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported the ab gripper has broken in half.
Additional Manufacturer Narrative
(b)(4).Investigation summary examination of the returned instrument confirmed the complaint.Depuy 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
Complaint description: it was reported the ab gripper has broken in half.
Additional Manufacturer Narrative
Product complaint # (b)(4).H1.Type of reportable event has incorrectly been reported as serious injury in (b)(4).Correct reportable event type is malfunction only.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE 60MM GRIPPER
• Common Device Name: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7161306
• Report Number: 1818910-2018-10009
• Device Sequence Number: 11228381
• Product Code: LXH
• UDI-Device Identifier: 10603295102328
• UDI-Public: 10603295102328
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2017

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 Model Number: 2218-90-060
• Device Catalogue Number: 221890060
• Device Lot Number: A0407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 07/12/2018; 03/04/2021
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 07/31/2018; 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1