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

Model Number	2545-00-999
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The following device was received as blind unit: product code: (b)(4), lot #: bfa118d.Arrived at cg labs on (b)(6) 2022, under tracking number: (b)(4).Issue - broken in two pieces.However, it could not be associated with a complaint or any other existing record.As a result, this complaint was created to analyze the returned device from (b)(4).This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the device associated with this report was returned for analysis.Visual examination found the brakeage of the main body of the device.Depuy synthese 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.Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial 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
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15696827
• Report Number: 1818910-2022-21517
• Device Sequence Number: 20538470
• Product Code: HWT
• UDI-Device Identifier: 10603295135760
• UDI-Public: 10603295135760
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2022

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: 2545-00-999
• Device Catalogue Number: 254500999
• Device Lot Number: BFA118D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown