MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ACET CUP INTRODUCER 32; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	962636000
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
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 small spring inside the plastic screw has loosened.Was surgery time extended as a direct result of incident? no.What action was taken/required to manage the problem during the procedure? with same like product.
Event or Problem Description
Additional information received: a.Was/were there any adverse consequence/s that affected the patient because of the reported event? - no adverse consequence for the patient.
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: event description of complaint (please supply specific details): small spring inside the plastic screw has loosened.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis found, the acet cup introducer 32 disassembled.All the components were returned for evaluation.The ejector plug had the heli-coil detached and presents signs of damage on the inner thread where the heli-coil should normally be threaded.Additionally, the heli-coil was found broken at the end, deformed and with several deep scratches all over the outer surface.The components were unable to be re-assemble, due to the observed condition of the heli-coil.The observed, condition of the device was consistent with a random component failure that may have been caused by exposure to unintended.And excessive forces applied to the ejector plug.When the instrument was disassemble or re-assembled following cleaning and sterilization process.Resulted in the damage to the heli-coil and ejector plug.The overall complaint was confirmed.As the observed, condition of the acet cup introducer 32 would contribute 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 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.
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.Added: d4 (lot), d9, h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ACET CUP INTRODUCER 32
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• 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: 18669508
• Report Number: 1818910-2024-02702
• Device Sequence Number: 8212278
• Product Code: HWR
• UDI-Device Identifier: 10603295243588
• UDI-Public: 10603295243588
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/08/2024

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: 962636000
• Device Lot Number: 0SA315673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 02/21/2024; 03/11/2024; 03/13/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 02/21/2024; 03/13/2024; 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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