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

Catalog Number	254500691
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, 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.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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
It was reported that on (b)(6) 2024, the inner metal ring in shim fell out due to crack on shim.There was no surgical delay.There were no patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "inner metal ring in shim fell out due to crack on shim.".The product was not returned to medtech orthopaedics; however photos were provided for review.See attachment " a-12174971 source data".The photo investigation of " 254500691, attune shim sz9 5mm" revealed that the device has cracked and metal ring of the shim has fell apart.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended user error.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune shim sz9 5mm would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to unintended use error and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of 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.Device history lot: the device lot number is unknown; therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.H11 additional narrative: added: b5.
Event or Problem Description
Additional information was received and stated that the instrument was broken into 2 pieces.

• 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 Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20818323
• Report Number: 1818910-2024-24598
• Device Sequence Number: 8716420
• Product Code: HWT
• UDI-Device Identifier: 10603295133636
• UDI-Public: (01)10603295133636
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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