MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CONV FB PS TB TRL SZ5; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number	2545-00-975
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: examination of the returned device found that the smaller balseal spring and post component was broken off at the base resulting in a hole in the bottom the trial.Root cause and corrective action are documented in the capa system.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
Event or Problem Description
It was reported that the ps insert trial found with hole worn into plastic piece was not used during procedure.No surgical delay.

• Brand Name: ATTUNE CONV FB PS TB TRL SZ5
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10689463
• Report Number: 1818910-2020-22544
• Device Sequence Number: 16873157
• Product Code: HWT
• UDI-Device Identifier: 10603295135524
• UDI-Public: 10603295135524
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2020

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 Model Number: 2545-00-975
• Device Catalogue Number: 254500975
• Device Lot Number: BFA0NDP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1