MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK ADAPTOR; ADAPTORS

Catalog Number UNK ADAPTOR

Device Problems Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919)

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

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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 during a tc3 knee revision in (b)(6) district general hospital this morning (b)(6) 2023, the deflection beam torque wrench instrument broke.This resulted in a 30 minute delay while the surgeon tried to release the adapter from the wrench.This wasn¿t successful; the adapter was therefore disassembled from the femur and a new adapter was acquired and fitted to the femur using an alternative instrument.Implant assembly was completed and implantation was achieved thereafter.

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.Added: b5, h6: medical device problem code.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received.Some developments, since we spoke.Upon closer examination, it was apparent, that the problem with the wrench was not, due to any defect in the instrument or implant involved, but simply a failure on the part of the surgeon to engage the wrench correctly with the implant.Thus, with the appropriate use of a spanner, the stem adapter was freed from the torque wrench, with no damage done.The torque wrench has been returned to the instrument tray from which it came.And a new stem adapter implant has been ordered by the hospital.The part it replaces has been discarded.I have delivered extra training to the staff to reduce the risk of a repeat of this event.Explaining that the stem adapter must be correct / fully engaged with the torque wrench, before the torque procedure.

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.

• Brand Name: UNK ADAPTOR
• Type of Device: ADAPTORS
• 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 46581-0988 ; 3035526892
• MDR Report Key: 16597049
• MDR Text Key: 312029089
• Report Number: 1818910-2023-06439
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2023

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: UNK ADAPTOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 03/30/2023; 04/11/2023
• Supplement Dates FDA Received: 04/05/2023; 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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