MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CONV SHIM SZ5 18MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number 254500932

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned instrument identified the device was broken.Depuy considers the investigation closed.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 will be filed as appropriate.

Event 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.

• Brand Name: ATTUNE CONV SHIM SZ5 18MM
• Type of Device: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6103142063
• MDR Report Key: 8273928
• MDR Text Key: 133971385
• Report Number: 1818910-2019-82128
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295135098
• UDI-Public: 10603295135098
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500932
• Device Lot Number: BFA0LK3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1