MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 PINNACLE 56MM GRIPPER; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	221890056
Medical Device Problem Codes	Break (1069); Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2018
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
Surgeon advised one of the plastic teeth on pinnacle ab gripper (size 56) broken requiring replacement.Unsure when this occurred & unable to locate plastic.
Additional Manufacturer Narrative
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).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.

• Brand Name: PINNACLE 56MM GRIPPER
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; . 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7221037
• Report Number: 1818910-2018-52080
• Device Sequence Number: 2379007
• Product Code: LXH
• UDI-Device Identifier: 10603295102304
• UDI-Public: 10603295102304
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2018

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: 221890056
• Device Lot Number: A1206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 04/18/2018; 07/19/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 05/09/2018; 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1