MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; BALL TIP DRIVER - HEX 3.5MM

Catalog Number	209-57-00
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending engineering evaluation.
Event or Problem Description
As reported, the instrument broke during surgery.There is no clue if the screw has been tight at its max.Tip snapped while tightening screw on base plate.The rep was present.The broken part was irretrievable from screw head and was left.The snapped tip is covered by insert and should not be able to loosen.There was no delay to the surgery.There was no delay to the surgery.
Additional Manufacturer Narrative
Device evaluated by mfr: the engineering evaluation noted the fractured ball tip driver reported in experience (b)(4) was likely the result of applying torque greater than the yield strength of the material, which lead to shearing off of the ball-tip, which was retained in the head of a screw used with the tibial tray.The torque limiting driver handle that should have been used in this case may be in need of calibration and may have contributed to the device fracture.However, this cannot be confirmed because the reported ball tip driver or a torque limiting driver handle was not returned for evaluation.*no information provided in the following section(s): a2, a3, a4, a5, b6, b7, d4 (expiration date), d7, h4.*the following section(s) have additional info: g4, g7, h1, h2, h3, h6, and h7.

• Brand Name: EXACTECH
• Common Device Name: BALL TIP DRIVER - HEX 3.5MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9069959
• Report Number: 1038671-2019-00458
• Device Sequence Number: 3934857
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2019

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: 209-57-00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other