MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SHIM SZ3 6MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number	2545-00-632
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the instruments are broken.No details as to how the damage occurred or the extent of the damage is provided only the items codes.
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Additional information was received indicating that "it is cracked but in one piece" depuy synthes joint reconstruction does not consider this failure to be a reportable malfunction at this time.Further updates will only be provided if additional information is received that changes the regulatory determination.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was returned for analysis.Examination of the returned device did not confirm the cracked condition.Instead, a chipped condition in several spots on the device was found.The reported complaint was not confirmed.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: b5, d9 corrected: h1, h3, h6 (clinical, impact and medical device problem codes).
Event or Problem Description
Additional information received indicated that the shim was cracked but in one piece.

• Brand Name: ATTUNE SHIM SZ3 6MM
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13266115
• Report Number: 1818910-2022-00966
• Device Sequence Number: 20023869
• Product Code: HWT
• UDI-Device Identifier: 10603295133346
• UDI-Public: 10603295133346
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 01/17/2022

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: 2545-00-632
• Device Catalogue Number: 254500632
• Device Lot Number: MVMBSL450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 01/20/2022; 03/31/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 02/04/2022; 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2013
• 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