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

Catalog Number	209-57-00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, the surgeon was torqueing the extension screw down in the tibial tray to lock down the stem.The tip of the ball driver broke inside the head of the extension screw.The surgeon was not able to remove the screw head, so it was left and the tibial tray was cemented in.The poly was also placed in over top locking into the mushroom.The incident did not create any problems during or after the case.The patient was alert and stable when leaving the room.
Additional Manufacturer Narrative
(h3) the evaluation noted that the fractured ball tip driver reported in the event 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 the stem extension screw.The torque limiting driver 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 torque limiting driver was not returned for evaluation.

• 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: 9458072
• Report Number: 1038671-2019-00602
• Device Sequence Number: 3094898
• Product Code: LXH
• UDI-Device Identifier: 10885862056696
• UDI-Public: 10885862056696
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 209-57-00
• Device Lot Number: 81566042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 04/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other