MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SHIM SZ9 6MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number	2545-00-692
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this report was returned for analysis.The photographic review confirmed a crack in the slot near the metal bushing area was observed.However visual examination of the returned device showed shim as broken.Breakage occurred at the crack reference taken by the photo evidence.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 will be filed as appropriate.
Event or Problem Description
During an inspection at the customer location it was noticed that the reported item have cracks.No fragments were created.No surgical delay.No adverse affects on the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was returned for analysis.The photographic review confirmed a crack in the slot near the metal bushing area was observed.However visual examination of the returned device showed shim as broken.Breakage occurred at the crack reference taken by the photo evidence.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 08/21/2014.3) any anomalies or deviations identified in dhr: the control plan features additionally handwritten documented 100% inspection for thickness using micrometers and bushings using gage 98430.No manufacturing irregularities related to the malfunction were identified.4) expiry date: n/a - reusable device.5) ifu reference: 090200836 rev d ifu ns surg instr.Device history review: a manufacturing record evaluation was performed for the finished device (254500692/bfa0shj) product and lot numbers, and no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: ATTUNE SHIM SZ9 6MM
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14577369
• Report Number: 1818910-2022-09983
• Device Sequence Number: 20370291
• Product Code: HWT
• UDI-Device Identifier: 10603295133643
• UDI-Public: 10603295133643
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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: 2545-00-692
• Device Catalogue Number: 254500692
• Device Lot Number: BFA0SHJ
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2017
• 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