MAUDE Adverse Event Report: ENCORE MEDICAL L.P 3.5MM HEX DRIVER, U-JOINT, 1/4IN SQUARE LOCKING; DRIVER, PROSTHESIS

Catalog Number	803-15-017
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The agent reported that (pin in screwdriver came out while using.) this event occurred during surgery, near the patient.No response was received by the surgeon.The surgery was completed as intended, with no 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 able to source a suitable replacement device.Rma examination: the instrument was returned to djo and after further examination, the dowel pin came out causing the hex tip to detach from the shaft, pin was not recovered a review of the instrument's device history record (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of this instrument.Complaint database review showed no previous complaints and there were no indications that this instrument has a design or material deficiency.The root cause of this complaint is likely attributable to damage incurred through misuse or rough handling which surgical instruments are subjected to.
Event or Problem Description
Instrument failure: instrument broke, pieceleft in patient.

• Brand Name: 3.5MM HEX DRIVER, U-JOINT, 1/4IN SQUARE LOCKING
• Common Device Name: DRIVER, PROSTHESIS
• 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: 19000681
• Report Number: 1644408-2024-00285
• Device Sequence Number: 15341142
• Product Code: HWR
• UDI-Device Identifier: 00190446289319
• UDI-Public: 00190446289319
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: B089254
• 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): 03/28/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 803-15-017
• Device Lot Number: 391294L12
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Female