MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CONV SHIM SZ7 18MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500944
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
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 the sterile processing advised that a number of shims from attune's shims and general tray were cracked and broken and could not be adequately and safely processed.It appears the shims broke during the was or sterilizer.
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device identified cracking.Depuy considers the investigation closed.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: ATTUNE CONV SHIM SZ7 18MM
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8235487
• Report Number: 1818910-2019-80454
• Device Sequence Number: 2370839
• Product Code: HWT
• UDI-Device Identifier: 10603295135210
• UDI-Public: 10603295135210
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/12/2018

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: 254500944
• Device Lot Number: BFA0MSG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1