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

Catalog Number	244000510
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2024
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the quick release mechanism was stiff and it was difficult to move.The surgical delay was unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9 corrected: d4 (lot, udi) and h4 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 Manufacturer Narrative
Product complaint (b)(4).Investigation summary : it was reported that the quick release mechanism was stiff of the instruments and it was difficult to move.The surgical delay was unknown.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the quickset ace grater handle had the sleeve missing.Signs of normal and repeated use were observed on the device, however no damage that could contribute to the reported event could be identified.A functional test was performed with a laboratory sample mating device, and the quickset ace grater handle was successfully assembled without any issues.However, a slight stiffness was observed in the retracting mechanism causing a difficulty in assembly.Therefore, the reported allegation can be confirmed.The observed condition was identified as indicator of end of life.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 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 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.The overall complaint was confirmed as the observed condition of the quickset ace grater handle would have contributed to the complained 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 lot:a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (a0810) provided is not a valid finished goods lot number.

• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21047516
• Report Number: 1818910-2024-26174
• Device Sequence Number: 16963729
• Product Code: HTO
• UDI-Device Identifier: 10603295123798
• UDI-Public: (01)10603295123798(10)A0810
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup,Followup,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: 244000510
• Device Lot Number: A0810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 01/15/2025; 01/20/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 01/15/2025; 01/16/2025; 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2010
• 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