MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET RGD DR SFT QCK CPLE; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	227453000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
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.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 instrument broke during the course of normal use.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.
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.
Event or Problem Description
Additional information was received: a.What is the event date? - as i said in my original complaint: ¿there have recently been a number of their consigned instrument trays taken out of circulation due to broken or damaged instruments.The broken or damaged instruments have been disposed of either in theatres or in cssd and the trays set aside, so i don¿t have any details on what happened with any of them, other than they were damaged or broken in the course of normal use.¿ these trays were taken out of circulation by the hospital, not by me, so i don¿t have any information as to when they did so.There are multiple trays and therefore probably multiple event dates, but none of the dates have been recorded by the hospital.B.Please clarify what you mean by damaged? is it broken into two pieces, dull, bent, cracked, stripped, worn, scratched, cross threaded or any device interaction issues? -again, i don¿t have any information on this but i can speculate that the drills probably got blunt or broke, the tibial impactors probably broke into 2 pieces (we¿ve had many of these break in half when they get old), the poly insert impactor probably cracked as it is plastic, and the 2 drivers probably stopped holding the drills properly.This is all guesswork based on failure modes that seem most likely for these instruments.

• Brand Name: QUICKSET RGD DR SFT QCK CPLE
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• 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: 19080262
• Report Number: 1818910-2024-08004
• Device Sequence Number: 6029930
• Product Code: HTW
• UDI-Device Identifier: 10603295109280
• UDI-Public: 10603295109280
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup,Followup
• Report Date (Section B): 04/10/2024

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: 227453000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 04/16/2024; 04/22/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 04/18/2024; 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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