MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 QUICKSET ACE GRATER HANDLE; HIP INSTRUMENTS : HANDLES

Catalog Number	244000510
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: investigation summary the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned devices found that both quickset ace grater handle have a foreign matter between the body and the retractable mechanism.However, the sleeve was missing.Additionally, the devices exhibited signs of usage.Potential cause can be traced to maintenance due to improper cleaning/sterilization process.Ifu specifies that "if the instrument has sliding mechanisms or hinged joints, actuate the area to free any trapped blood and debris", and to "actuate sliding mechanisms and hinged joints while rinsing.Dry immediately after final rinse.Dry internal areas with filtered compressed air, if available.Lubricate moving parts with a watersoluble lubricant, if applicable.Inspect all instruments prior to sterilization or storage to ensure instruments are suitable for use".Properly handling and¿attention to the approved use of the device diminishes the risk of failure.The missing condition 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 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 revealed that although the retrieval/release mechanism could move in its intended direction, a resistance was found for this component due to the foreign matter being trapped in the mechanism.The overall complaint was confirmed as the observed condition of the quickset ace grater handle would have contributed to a 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 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 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.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
The devices were reported for an unknown reason/malfunction.It didnt happen in surgery.

• Brand Name: QUICKSET ACE GRATER HANDLE
• Common Device Name: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22511781
• Report Number: 1818910-2025-12178
• Device Sequence Number: 9265022
• Product Code: HTO
• UDI-Device Identifier: 10603295123798
• UDI-Public: (01)10603295123798(10)SO2017783
• Combination Product (Y/N): N
• 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: 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: 244000510
• Device Lot Number: SO2017783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2015
• 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