MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE SHIM SZ5 6MM; TIBIAL INSERT TRIALS

Catalog Number 254500652

Device Problem No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary the instrument was reported for unknown reason.The device associated with this report was returned to depuy synthes for evaluation.Investigation revealed that the device is broken in two pieces from half.It is also observed the device edges are chipped off.The failure mode is consistent with using a device in a prying motion to disassemble the mating instruments after trialing resulting in material overload at the smallest cross-sectional area in middle of the shim.No material or manufacturing defects were observed that would have contributed to the fracture.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 confirmed as the observed condition of the attune shim sz5 6mm would have contributed to the device issue.Based on the investigation findings, the potential cause is traced to unintended use error, and it has been determined that no corrective and/or preventative action is proposed.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.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 Description

The instrument was reported for unknown reason.Visual exam of the returned device found that the device is broken in two pieces from half.It is also observed the device edges are chipped off.

• Brand Name: ATTUNE SHIM SZ5 6MM
• Type of Device: TIBIAL INSERT TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18951668
• MDR Text Key: 338262989
• Report Number: 1818910-2024-06281
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295133445
• UDI-Public: 10603295133445
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500652
• Device Lot Number: MVMHBD620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1