MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATUN REV SLEV CONTR TORQ WRNCH; TORQUE DEVICES

Catalog Number	254600421
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
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
It was reported that during assembly of the femoral attune sleeve stem construct, the sleeve wrench would not strip/slip around as the surgeon torqued it with the torque wrench.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary evaluation and functional testing of the returned device was unable to confirm the reported event.The returned device functions as intended.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATUN REV SLEV CONTR TORQ WRNCH
• Common Device Name: TORQUE DEVICES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8032530
• Report Number: 1818910-2018-74287
• Device Sequence Number: 11088411
• Product Code: HXC
• UDI-Device Identifier: 10603295440345
• UDI-Public: 10603295440345
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2018

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: 254600421
• Device Lot Number: PG270663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 11/05/2018; 11/21/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 11/06/2018; 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR