MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. US 1818910 P.F.C. T-HANDLE; HIP INSTRUMENTS : IMPACTORS

Catalog Number	853965
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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
It was reported that the surgeon was using the t-handle to ream the femoral canal and the t-handle was not turning the reamers anymore and the t-handle adapter was stripped.
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.
Additional Manufacturer Narrative
Product complaint # : (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: P.F.C. T-HANDLE
• Common Device Name: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8119559
• Report Number: 1818910-2018-76725
• Device Sequence Number: 16551881
• Product Code: JDI
• UDI-Device Identifier: 10603295207801
• UDI-Public: 10603295207801
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K952859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2018

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: 853965
• Device Lot Number: AK0601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 01/28/2019; 01/03/2019
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 01/01/2019; 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1