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

Catalog Number	227453000
Medical Device Problem Codes	Device-Device Incompatibility (2919); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/10/2023
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
The drill flexible handle is damaged; it does not hold the drill.When using with the engine, the drill bit is released from the flexible drill bit holder.There was a 5 minute surgical delay.
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.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 is 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, it was reported that the drill flexible handle is damaged; it does not hold the drill.When using with the engine, the drill bit is released from the flexible drill bit holder.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned device found that the ball plunger of the quickset rgd dr sft qck cple does not retract causing that the locking mechanism does not work correctly.The locking mechanism appearance was worn and slightly stripped.A complete functional test was not performed since the mating device was not returned.However, the coupling connection of the device was checked manually, and it was detected that the mechanism does not work as intended, the reported unable to assemble condition can be confirmed.A search of the complaint database found similar reports and the potential cause could be related to the customer removing the drill bit before the drill bit holder is in the unlocked position stripping the locking mechanism.A dimensional inspection for the device was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the quickset rgd dr sft qck cple would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error, 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 review of the receiving inspection (ri) was performed for the finished device [227453000 / so2057315] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.

• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18265547
• Report Number: 1818910-2023-24550
• Device Sequence Number: 15371678
• Product Code: HTW
• UDI-Device Identifier: 10603295109280
• UDI-Public: (01)10603295109280(10)SO2057315
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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,Followup
• Report Date (Section B): 12/05/2023

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
• Device Lot Number: SO2057315
• 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: 11/10/2023
• Supplement Date Received by Manufacturer: 12/14/2023; 04/26/2024; 08/15/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 12/15/2023; 04/30/2024; 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2022
• 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