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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNK ADAPTOR; ADAPTORS Back to Search Results
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.
 
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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 Key16597049
MDR Text Key312029089
Report Number1818910-2023-06439
Device Sequence Number1
Product Code HTO
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
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 NumberUNK ADAPTOR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/02/2023
Initial Date FDA Received03/23/2023
Supplement Dates Manufacturer Received03/30/2023
04/11/2023
Supplement Dates FDA Received04/05/2023
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 Number1
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