MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DUR POLY IMPACTOR HANDLE; HIP INSTRUMENTS : IMPACTORS

Catalog Number	201524000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2017
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 that the pinnacle ultamet metal on metal liner extractor broke during removal of a metal on metal liner.Both the liner remover and the impactor handle broke during the case.All pieces were retrieved, nothing left in the patient.No surgical delay.
Additional Manufacturer Narrative
Product complaint #: (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.

• Brand Name: DUR POLY IMPACTOR HANDLE
• Common Device Name: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7201433
• Report Number: 1818910-2018-51441
• Device Sequence Number: 1043264
• Product Code: HWA
• UDI-Device Identifier: 10603295082408
• UDI-Public: 10603295082408
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2017

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 Catalogue Number: 201524000
• Device Lot Number: AG0902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Initial Date Received by Manufacturer: 12/29/2017
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 100