MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US RETAINING STEM INSERTER; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	259807570
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2026
Type of Reportable Event	Malfunction
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.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.H3, h6: product investigation: the product returned to depuy synthes for evaluation.Visual analysis revealed that the distal threaded tip of the rod weldment was broken; broken fragment and the retaining stem inserter body were not returned for evaluation.Although no cracks were identified, the breakage can be the result of an initial crack, therefore reported allegation can be substantiated.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces, such as, impaction forces while the device is not fully o properly assemble, heavy usage or excessive force in a prying motion.Properly handling and attention to the approved use of the device diminishes the risk of failure.Missing body may occur during the cleaning/sterilization process, particularly when the components are assembled or disassembled.As these procedures are often repeated, there is an increased risk of components going missing.However, without concrete evidence or further information, it is not possible to determine a root cause.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 retaining stem inserter would have contributed to the complained device issue.Based on the investigation findings, 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 reported complaint condition.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 a manufacturing records evaluation (mre) was not performed as no lot number was retrieved due to the worn condition.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 the threaded insert tip was cracked when inserting stem.

• Brand Name: RETAINING STEM INSERTER
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 25082581
• Report Number: 1818910-2026-08212
• Device Sequence Number: 10532914
• Product Code: HWR
• UDI-Device Identifier: 10603295148548
• UDI-Public: (01)10603295148548
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 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: 259807570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/05/2026
• 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: Female