MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE REV SLAPHMR ADPTR IMPLNT; ADAPTORS

Model Number	2546-00-461
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
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 the broach handles were disengaging from broach.Threaded extractor stripped thread upon use.There was a surgical delay of 20 minutes.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: examination of the returned device confirms the reported stripped threads.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: corrected: h3.

• Brand Name: ATUNE REV SLAPHMR ADPTR IMPLNT
• Common Device Name: ADAPTORS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10514803
• Report Number: 1818910-2020-19771
• Device Sequence Number: 19734246
• Product Code: HWB
• UDI-Device Identifier: 10603295440505
• UDI-Public: 10603295440505
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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 Model Number: 2546-00-461
• Device Catalogue Number: 254600461
• Device Lot Number: NW204195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR