MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CONV SHIM SZ3 12MM; TIBIAL INSERT TRIALS

Catalog Number	254500917
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: h3, h6: a product investigation was completed: 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.Visual inspection of the returned device revealed that the attune conv shim sz3 12mm was found broken around the right metal insert and it was observed cracked around the left metal insert.No other issues were observed.Therefore, the reported condition can be confirmed.The thermal properties of the metal bushing and radel trial body are different resulting in the material to expand and contract at different rates.This puts a significant amount of stress on interfacing materials.Radel, being highly brittle, will succumb to these thermal stresses in the form of stress cracking.This cracking can be accelerated by high frequency autoclave cycles and/or the use of harsh chemicals, however, it is recognized these outside contributing factors act as a catalyst to the propagation of the cracks which ultimately can lead to catastrophic failure of the shims.Due to crack propagation being recognized as an inherent risk of the shims after repeated use, the potential cause is traced to end of life.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was unable to be performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune conv shim sz3 12mm would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Event or Problem Description
It was reported on (b)(6) 2024 while putting set together, cracks were found in a 3/4 12mm shim.It was not used in the case.Visual inspection of the returned device revealed that the attune conv shim sz3 12mm was found broken around the right metal insert and it was observed cracked around the left metal insert.

• Brand Name: ATTUNE CONV SHIM SZ3 12MM
• Common Device Name: TIBIAL INSERT TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20644018
• Report Number: 1818910-2024-23375
• Device Sequence Number: 15321203
• Product Code: HWT
• UDI-Device Identifier: 10603295134947
• UDI-Public: (01)10603295134947(10)BFA0RE0
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Catalogue Number: 254500917
• Device Lot Number: BFA0RE0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2014
• 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: Female