MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN REV BROACH ADPTR SZ 1-3; ADAPTORS

Model Number	2504-40-500
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
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
Surgeon tried to over-tighten screws attaching the 1-3 broach adapter to size 3 ap cutting block.In doing so, appears to have cross-threaded the left hand screw of the broach adapter and thread on inside of ap cutting block.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint # (b)(4).Investigation summary - the products were returned to engineering dept at depuy australia where they were assessed by the engineering technician who confirmed the complainants findings.It was deemed that the complaint was due to wear and tear.Device history lot - null.Device history batch - null.Device history review - null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATUN REV BROACH ADPTR SZ 1-3
• Common Device Name: ADAPTORS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9656016
• Report Number: 1818910-2020-03745
• Device Sequence Number: 11189855
• Product Code: LXH
• UDI-Device Identifier: 10603295438250
• UDI-Public: 10603295438250
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2020

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: 2504-40-500
• Device Catalogue Number: 250440500
• Device Lot Number: GM4994708
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1