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	05/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
During a revision from a primary to a cc.It has happened while locking the insert to the base plate, 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
H10: (h3) the evaluation of the of the reported event may be the result of was 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.No information provided in the following section(s): a2,a3, a4, a5, b6, b7, g5, and h4.The following section(s) have additional info: g4, g7, h1, h2, h3, and h7.

• Brand Name: EXACTECH
• Common Device Name: TORQUE LIMITING DRIVER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10298722
• Report Number: 1038671-2020-00352
• Device Sequence Number: 11627587
• 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): 02/11/2021

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: Health Professional
• Device Catalogue Number: 209-30-00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 02/11/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Other