MAUDE Adverse Event Report: DEPUY IRELAND 9616671 RECLAIM REAMER T-HANDLE; HIP INSTRUMENT/TRIAL

Catalog Number	297500510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	06/20/2017
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 handle will not hold in a ratchet position to enable turning of reamer.August 25, 2017 - evaluation of the returned instrument found the attachment components broke off the handle.Tiny screw and spring components were found that broke from the attachment component.
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary: examination of the returned instrument confirmed the reported observation.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: RECLAIM REAMER T-HANDLE
• Common Device Name: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork IN ; EI
• MDR Report Key: 6984675
• Report Number: 1818910-2017-27703
• Device Sequence Number: 16265479
• Product Code: HTO
• UDI-Device Identifier: 10603295155935
• UDI-Public: 10603295155935
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2017

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: 297500510
• Device Lot Number: A1210A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1