MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HANDLE; HIP INSTRUMENTS : HANDLES

Catalog Number 244000510

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The following device was received as blind unit.Visual exam found device exhibits rust/ corrosion.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: according to the information received: the following device was received as blind unit.The product was returned to depuy synthes for evaluation.As part of visual inspection, a foreign substance was found at the distal connector feature.According to ifu-0902-00-721, the instrument should be disassembled for cleaning process.Additionally, 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.Based on the observed condition of the device the potential cause can be attributed to maintenance.A dimensional inspection and functional inspection were not performed since it were 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 a device issue.Based on the investigation findings, the potential cause is improper 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 a0309 provided is not a valid finished goods lot number.

• Brand Name: QUICKSET ACE GRATER HANDLE
• Type of Device: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18437200
• MDR Text Key: 331985620
• Report Number: 1818910-2024-00253
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295123798
• UDI-Public: 10603295123798
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 244000510
• Device Lot Number: A0211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1