MAUDE Adverse Event Report: ENCORE MEDICAL L.P T-HANLDE, QUICK COUPLING RSP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 804-03-019

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 04/04/2023

Event Type  Injury  

Event Description

Instrument failure with a 30 minute delay in surgery.

Manufacturer Narrative

The agent reported (pieces bound together.Male, 64) this event occurred during treatment, near the patient.No response was received from the surgeon.The surgery was completed as intended, with a thirty-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was not able to source a suitable replacement device.The instrument was returned to djo and was escalated for further evaluation.A review of the device history record (dhr) revealed the instruments, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of this instrument.Complaint database review showed 1 previous complaint but there were no indications that this instrument has a design or material deficiency.It has been determined that there is no fault of the t- handle.The instrument was able to lock and release its counterpart with no issue.

• Brand Name: T-HANLDE, QUICK COUPLING RSP
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 16827799
• MDR Text Key: 314161284
• Report Number: 1644408-2023-00486
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888912147958
• UDI-Public: 00888912147958
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 804-03-019
• Device Catalogue Number: 804-03-019
• Device Lot Number: 207198L05
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 804-03-008 LOT: 315737L10; 804-03-020 LOT: 289264L05
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male