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

Model Number	804-03-019
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Instrument failure with a 30 minute delay in surgery.
Additional 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
• Common Device Name: 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
• Report Number: 1644408-2023-00486
• Device Sequence Number: 7566591
• Product Code: LXH
• UDI-Device Identifier: 00888912147958
• UDI-Public: 00888912147958
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 804-03-019
• Device Catalogue Number: 804-03-019
• Device Lot Number: 207198L05
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2016
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 804-03-008 LOT: 315737L10; 804-03-020 LOT: 289264L05
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male