MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CONV RP PS TB TRL SZ9; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500999
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 trial extractor and articulating surface broke during removal of trials.All pieces of the extractor were not retrieved.The wound was searched thoroughly and nothing was found.The trial and extractor are being sent to risk management so they will not be returned.Surgical delay: 5-10 mins.All pieces of the extractor were not retrieved.
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 IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7540960
• Report Number: 1818910-2018-60429
• Device Sequence Number: 1871838
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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: 04/26/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 07/04/2018
• 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