MAUDE Adverse Event Report: DePuy Orthopaedics Inc US ATTUNE; Attune Instruments : Impactors

Catalog Number	254401006
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an attune trial extractor broke while removing a trial insert.The single broken piece was recovered.It was also noted that the attune femoral impact impactor had cracks in it.
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 narrative: h3, h6: investigation summary the product was returned to depuy synthes for evaluation, and an investigation was conducted in accordance with depuy synthes procedures.Visual inspection of the returned device found that it was broken at the anterior section, the fragments were not returned for evaluation.Additionally some cracks were observed near the breakage region.No other anomalies were noted.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.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.The reported complaint was confirmed based on the evaluation results.The investigation traced the potential cause to end of life.It has been determined that no corrective or preventive actions are proposed.There is no indication that a design or manufacturing issue caused the reported condition.As part of depuy synthes quality processes, all devices are manufactured, inspected, and released in accordance with approved specifications.Additional monitoring for potential safety signals is conducted through complaint trend analysis as part of post-market safety surveillance activities.Device history review 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.

• Brand Name: ATTUNE
• Common Device Name: Attune Instruments : Impactors
• Manufacturer (Section D): DePuy Orthopaedics Inc US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50872052
• Report Number: 1818910-2026-16451
• Device Sequence Number: 21511838
• Product Code: HWA
• UDI-Device Identifier: 10603295130222
• UDI-Public: (01)10603295130222(10)3357853
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 254401006
• Device Lot Number: 3357853
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male