MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CONV RP PS TB TRL SZ7; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number	2545-00-997
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Broken attune shim reported by cssd staff.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) investigation summary = > the returned instrument was assessed by depuy australia and the complainants findings confirmed.The assessment was that the complaint was due to wear and tear.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.

• Brand Name: ATTUNE CONV RP PS TB TRL SZ7
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10116372
• Report Number: 1818910-2020-13147
• Device Sequence Number: 2319708
• Product Code: JWH
• UDI-Device Identifier: 10603295135746
• UDI-Public: 10603295135746
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2020

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: 2545-00-997
• Device Catalogue Number: 254500997
• Device Lot Number: BFA0HYW
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 07/07/2020
• Patient Sequence Number: 1