MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DURALOC; HIP INSTRUMENTS : IMPACTORS

Catalog Number	224408000
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the mechanism is jamming and the handle can¿t be used anymore.There was no surgical delay and no patient consequence.
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: h3, h6: product investigation summary: the product was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that the duraloc curved cup impactor the cup connector jammed with the shaft.Additionally, the device exhibits an overall worn appearance consistent with heavy and constant usage.The assessment was performed manually and was able to confirm the reported allegation, the devices were unable to disengaged after multiple attempts with excessive forces applied.Improper cleaning and drying may be a contributing factor along with heavy usage through the operational time at service.As per the ifu-0902-00-721 rev.K it is recommended to use a soft bristle brush to remove all traces of blood and debris, paying close attention to threads, crevices, seams, and any hard-to-reach areas.If the instrument has sliding mechanisms or hinged joints, actuate the area to free any trapped blood and debris.Additionally, the document suggests drying immediately after final rinse.Dry internal areas with filtered compressed air, if available and lubricate moving parts with a water-soluble lubricant, if applicable.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 duraloc curved cup impactor would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to maintenance, and it has been determined that no corrective and/or preventative action is required.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 device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (a1007) provided is not a valid finished goods lot number.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DURALOC
• Common Device Name: HIP INSTRUMENTS : IMPACTORS
• 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: 25553456
• Report Number: 1818910-2026-10435
• Device Sequence Number: 18832056
• Product Code: HWA
• UDI-Device Identifier: 10603295107477
• UDI-Public: (01)10603295107477(10)A1007
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 224408000
• Device Lot Number: A1007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2007
• 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