MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CONV SHIM SZ3 18MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500920
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned instrument identified the device was broken.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
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 shims broke during the wash or sterilizer.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ATTUNE CONV SHIM SZ3 18MM
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8273909
• Report Number: 1818910-2019-82126
• Device Sequence Number: 2081361
• Product Code: HWT
• UDI-Device Identifier: 10603295134978
• UDI-Public: 10603295134978
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

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: 254500920
• Device Lot Number: BFA0RF7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 01/24/2019
• Patient Sequence Number: 1