MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 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	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the quick release mechanism was stiff and difficult to move.Surgical delay was unknown.
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.
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 that 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 that was not available for the initial report is obtained, 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 is stiff and difficult to move.Surgical delay was unknown.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed a foreign matter in between the device and it release/retrieval mechanism.Additionally, device exhibited signs of heavy usage.Potential cause can be traced to maintenance due to improper cleaning/sterilization process.Ifu-0902-00-721 rev.L 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.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.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 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 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 ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21047563
• Report Number: 1818910-2024-26178
• Device Sequence Number: 16963497
• 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

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; 01/27/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 01/14/2025; 01/28/2025
• 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: Male