MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE CONV RP PS TB TRL SZ9; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500999
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2018
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
Maude report received.Doctor was performing a l tka (total knee arthroplasty).While removing articulating surface trial, the trial, as well as the trial extractor broke.The trial was removed in its entirety.All pieces of the trial extractor, however, were not encountered for.The wound was thoroughly searched and irrigated thoroughly, and no evidence of foreign bdy was found.The trial and trial extractor were sequestered and sent to risk for evaluation and reporting.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the device associated with this report was not returned.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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: ATTUNE CONV RP PS TB TRL SZ9
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7813502
• Report Number: 1818910-2018-67641
• Device Sequence Number: 11063746
• Product Code: JWH
• UDI-Device Identifier: 10603295135760
• UDI-Public: 10603295135760
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K140881
• 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): 08/01/2018

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: 254500999
• Device Lot Number: BFA0RRF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 12/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR