MAUDE Adverse Event Report: EXACTECH, INC. NOV 6.5MM HEX DRIVER ARTICULATING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	NOV 6.5MM HEX DRIVER ARTICULATING
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported during surgical use, the surgeon performed tha procedure and during this surgery, surgeon encountered a incident that a tip of driver was disassembled and all parts except for one shaft was retrieved from surgical field and operation room.Using the imaging machine, he checked if a shaft was left in patient body.As a result, there was not found out a shaft in patient body.There was a 31-45 min surgical delay/prolongation.There was no adverse event as a result of the surgical delay.Patient was last known to be in stable condition following the event.Image received.Sales rep was unable to obtain x-ray.Device is available for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the broken tip driver reported may have been due to the press-fit dowel pin backing out as a result of numerous surgical uses and subsequent sterilization cycles, which led to ultimate disassembly of the tip and washer subcomponents from the device.The most probable root cause associated with the reported event of ¿disassembled / misassembled¿ is associated with the unwanted disassembly of the device, or incorrect assembly of the device (attaching mating instrumentation incorrectly, assembling an implant construct off-axis, etc.).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h11.Upon reassessment of the reported event, it was determined that the event did not involve a death or serious injury nor would be likely to cause or contribute to a death or serious injury if the reported malfunction were to recur.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• Brand Name: NOV 6.5MM HEX DRIVER ARTICULATING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15833537
• Report Number: 1038671-2022-01488
• Device Sequence Number: 5427342
• Product Code: LXH
• UDI-Device Identifier: 10885862038661
• UDI-Public: 10885862038661
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2025

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
• Operator of Device: Health Professional
• Device Model Number: NOV 6.5MM HEX DRIVER ARTICULATING
• Device Catalogue Number: 181-65-02
• Device Lot Number: 401791001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 02/28/2023; 09/29/2025
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 03/21/2023; 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown