MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 PINNACLE 52MM GRIPPER; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	221890052
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/08/2018
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
Total hip replacement, (b)(6) hospital, (b)(6) 2018.Implant retaining clips snapped off during implantation.Another tray of instruments opened.Ten minutes delay in surgery.No ae to patient.
Additional Manufacturer Narrative
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Product complaint # = > pc-(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.

• Brand Name: PINNACLE 52MM GRIPPER
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7395272
• Report Number: 1818910-2018-56630
• Device Sequence Number: 18980686
• Product Code: LXH
• UDI-Device Identifier: 10603295102281
• UDI-Public: 10603295102281
• 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): 03/08/2018

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: 221890052
• Device Lot Number: SO2008262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 05/04/2018; 07/12/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/10/2018; 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1