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	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.No information provided in the following section(s).
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
After further review of additional information received the following sections d9, g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the fractured ball tip drivers reported may have been the result of using one of the torque limiting drivers that clicked over at a torque greater than 64 in-lbs., possibly due to corroded internal mechanisms.However, this cannot be confirmed as it is unclear which of the four torque limiting drivers from arago were used with the ball tip drivers when the fractures occurred.The higher torque values and/or reported ball tip driver breakages may also have been the result of a process failure as the torque testing process implemented in usa for instruments being serviced after return from the field prior to re-stocking was not implemented at all global offices.The most probable root cause associated with the reported event of "broken - minor surgical delay¿ is associated with a partial or full-thickness crack in the device materials.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2020-00344, 1038671-2020-00345, 1038671-2020-00656, 1038671-2020-00657 and 1038671-2020-00658.

• Brand Name: EXACTECH
• Common Device Name: BALL TIP DRIVER - HEX 3.5MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate kate.jacobson@exac.com ; 3523782617
• MDR Report Key: 10296497
• Report Number: 1038671-2020-00344
• Device Sequence Number: 14317267
• 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): 04/28/2022

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: Health Professional
• Device Catalogue Number: 209-57-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown