MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ZT TRIAL SLEEVE 20B SML; FEMORAL TRIALS

Catalog Number	257620100
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the instrument was difficult to extract.
Additional Manufacturer Narrative
J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, 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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : it was reported that the instrument was difficult to extract.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device found that the zt trial sleeve 20b sml present heavy signs of deformation at the superior corners of the insertion hole and at the bottom section.Additionally the sample presents signs of repetitive use for a long period of time.A functional test could not be performed as the mating device was not returned.However, the assembly issues could be confirmed due to the observed deformed and wear conditions of the device.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.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the zt trial sleeve 20b sml would have contributed to the complained 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.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j 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 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.Corrected: h3.

• Brand Name: ZT TRIAL SLEEVE 20B SML
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22210893
• Report Number: 1818910-2025-09733
• Device Sequence Number: 12948834
• Product Code: HWT
• UDI-Device Identifier: 10603295146735
• UDI-Public: (01)10603295146735(10)MT40876
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• 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: 257620100
• Device Lot Number: MT40876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2021
• 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