MAUDE Adverse Event Report: ENCORE MEDICAL L.P DJO SURGICAL; DRIVER, 3.5MM POWER HEX RSP

Catalog Number	804-03-022
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported "the screwdriver tip broke off in the baseplate.It broke cleanly off and was not about to be pulled out.The baseplate had to be removed with pliers and another baseplate had to be used." "item number: 804-03-022", item description: driver, 3.5mm power hex rsp, lot#: 440024l01, part revision: a, product type: shoulder, manufacture date: 10-sep-2025, possible time in service: 7 months, 26 days.This event occurred during surgery, near the patient.The surgeon reported significant adverse event.There was a delay in surgery but the period of the delay was not documented.The instrument was inspected prior to use and deemed acceptable based on its appearance.The agent was present during surgery and was able to source a suitable replacement.Rma examination: the reported instrument was returned to enovis surgical for evaluation, and the reported problem was confirmed.Root cause: the root cause of this complaint was a fracture of the driver, 3.5mm power hex rsp tip during use likely due to excessive torsional stress applied to the driver tip.This event is not considered indicative of a product defect or malfunction.Containment: there are no indications that the instrument has a design or material deficiency.Therefore, no inventory containment is required.The event is associated with instrument usage, not a design or manufacturing issue.Device history records review: a review of the instrument's device history records (dhr) revealed, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of the instrument that is related to the reported issue.Complaint history: the customer complaint history for the reported device(s) showed no current trends or ongoing issues that require review.
Event or Problem Description
Revision surgery due to the screwdriver tip broke off in the baseplate.It broke cleanly off and was not about to be pulled out.The baseplate had to be removed with pliers and another baseplate had to be used.

• Brand Name: DJO SURGICAL
• Common Device Name: DRIVER, 3.5MM POWER HEX RSP
• 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: stacey bonnell ; 9800 metric blvd.; austin, PW 78758
• MDR Report Key: 25365925
• Report Number: 1644408-2026-01030
• Device Sequence Number: 9977606
• Product Code: HWR
• UDI-Device Identifier: 00888912147989
• UDI-Public: 00888912147989
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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): 05/29/2026

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 Catalogue Number: 804-03-022
• Device Lot Number: 440024L01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown