MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SHIM SZ9 5MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500691
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trial tibia and shims were broken during trial removal during the case.All parts were accounted for and retrieved from the surgical field.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a1, a2, a4, d9.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
Additional information was received: a.Was there any surgical delay related to the event? if yes, what is the duration of the delay? no delay.B.Was there any patient harm/consequence related to the event? no harm.C.Did the instrument broke into 2 or more pieces? tibial trial was in 2 pieces.Both retrieved easily.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that size 8 rp trial tibia and 5mm 9/10 shims were broken during trial removal during the case.All parts were accounted for and retrieved from the surgical field.The product was returned to depuy synthes for evaluation and photos were provided for review.Visual inspection of the returned device and photo evidence found that broken condition was not found.Furthermore, the device was cracked from near a metal ring.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 not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the attune shim sz9 5mm would not contributed to the complained device 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.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: 1) quantity manufactured: (b)(4).2) date of manufacture: 02/20/2014 to 02/28/2014.3) any anomalies or deviations identified in dhr: dhr is missing documentation that was in the dmr.Bushing receiving inspection sheet has reduced inspection documented without rationale.4) expiry date: n/a.5) ifu reference: 090200836 rev c ifu ns surg instr.

• Brand Name: ATTUNE SHIM SZ9 5MM
• 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: 19298325
• Report Number: 1818910-2024-10451
• Device Sequence Number: 6882776
• Product Code: HWT
• UDI-Device Identifier: 10603295133636
• UDI-Public: 10603295133636
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup,Followup
• Report Date (Section B): 05/13/2024

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: 254500691
• Device Lot Number: BFA0WM5
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 06/11/2024; 06/21/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/11/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2017
• 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 Age: 72 YR
• Patient Sex: Unknown
• Patient Weight: 105 KG