MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 QUICKSET RATCHET SCDR HDL; HIP INSTRUMENTS : HANDLES

Catalog Number 227402000

Device Problem Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 07/29/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the screwdriver handle wouldn't ratchet properly and screwdriver shank wouldn't securely hold screw.

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.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected h3.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: it was reported that the screwdriver handle wouldn't ratchet properly and screwdriver shank wouldn't securely hold screw.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned sample revealed that the quickset ratchet scdr hdl was observed cracked from black handle and a high wear was observed on the handle due to use.A functional test was performed and it was observed that the coupling with quickset tprd hex scdr cardan was correct, the separation of the coupling was correct, no defects were detected in the coupling mechanism.The reported condition cannot be confirmed.The broken condition was identified as an end of life indicator; damage consistent with repeated use and servicing.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.A dimensional inspection was not performed as it is not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the quickset ratchet scdr hdl would not have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, 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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: QUICKSET RATCHET SCDR HDL
• Type of Device: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17558138
• MDR Text Key: 321544893
• Report Number: 1818910-2023-16885
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10603295109020
• UDI-Public: 10603295109020
• 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,Followup
• Report Date: 08/16/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 227402000
• Device Lot Number: BA1295B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 09/01/2023; 09/11/2023
• Supplement Dates FDA Received: 09/02/2023; 09/12/2023
• 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