MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CONV SHIM SZ5 12MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500929
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that the attune shims are cracked and need to be replaced.The event did not happen in surgery.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that the attune conv shim sz5 12mm was broken already from the cracked portion around one of the metal inserts, therefore the complaint can be confirmed.Regarding the crack, 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 functional test was unable to be performed since it was not applicable to the complaint condition.A dimensional inspection was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune conv shim sz5 12mm would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to end of life.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes 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.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.H6: component code: appropriate term/code not available (g07002) used to capture no findings available.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the attune shims are cracked and need to be replaced.The event did not happen in surgery.Additional event information provided by sales rep states that the shims have cracks in them but they did not break into two or more pieces.

• Brand Name: ATTUNE CONV SHIM SZ5 12MM
• 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: 18072799
• Report Number: 1818910-2023-22563
• Device Sequence Number: 7759108
• Product Code: HWT
• UDI-Device Identifier: 10603295135067
• UDI-Public: 10603295135067
• 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
• Report Date (Section B): 11/06/2023

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: 254500929
• Device Lot Number: BFA0RGL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2014
• 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: Unknown