MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REVISION MODULAR STOP; ATTUNE STEMMABLE TIBIA INSTRUMENTS : DRILL GUIDES

Catalog Number	254600500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation of the returned device did not identify any breakage as reported, however functional testing with a depuy retained reamer finds the returned modular stop does not assemble to the mating device as intended.Depuy considers the investigation closed at this time.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 or Problem Description
It was reported that instrument was broken during sterilization.
Event or Problem Description
Evaluation and functional testing of the returned device finds the modular stop will not assemble to the mating part as intended.No breakage was identified.

• Brand Name: ATTUNE REVISION MODULAR STOP
• Common Device Name: ATTUNE STEMMABLE TIBIA INSTRUMENTS : DRILL GUIDES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7931426
• Report Number: 1818910-2018-71221
• Device Sequence Number: 11246863
• Product Code: LXH
• UDI-Device Identifier: 10603295478607
• UDI-Public: 10603295478607
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/21/2018

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: 254600500
• Device Lot Number: SO2029584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1