MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; TORQUE LIMITING DRIVER

Catalog Number	209-30-00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
During a revision from a primary to a cc, while locking the insert to the base plate, the ball tip driver broke, resulting in major difficulties to retrieve the broken tip left in the screw head.All pieces were retrieved, with less than 5 min delay to surgery.The tip was discarded and will not return, the driver will be returning.No patient info provided.
Additional Manufacturer Narrative
(h3) the evaluation noted that revision reported was likely the result of applying torque greater than the yield strength of the ball tip driver¿s material, which lead to shearing off of the ball-tip.However, this cannot be confirmed as the ball tip driver was not available for evaluation.The most probable root cause associated with the reported event of "broken" is associated with a partial or full-thickness crack in the device materials.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2020-00350, 1038671-2020-00351 and 1038671-2020-00645.

• Brand Name: EXACTECH
• Common Device Name: TORQUE LIMITING DRIVER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10298663
• Report Number: 1038671-2020-00351
• Device Sequence Number: 11627586
• Product Code: LXH
• UDI-Device Identifier: 10885862056696
• UDI-Public: 10885862056696
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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: No Information
• Device Catalogue Number: 209-30-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 05/18/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other