MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; 45 DEGREE FIXED ANGLE DRIVER-OTHY

Catalog Number	101-05-46
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending engineering evaluation.
Event or Problem Description
After drilling for a screw, drill bit stayed in bone as a result of the end of the drill handle breaking.All pieces were retrieved, no delay to surgery and no adverse effects to the patient.Patient left the room stable.Note: this complaint was never email or phone in.Complaints were notified upon receiving of device from coc.
Additional Manufacturer Narrative
Section h10: (h3) the engineering evaluation noted the broken instrument reported was likely the result of crack initiation, propagation, and ultimate fracture of the brittle tines from years of normal use.

• Brand Name: EXACTECH
• Common Device Name: 45 DEGREE FIXED ANGLE DRIVER-OTHY
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9120538
• Report Number: 1038671-2019-00468
• Device Sequence Number: 10902830
• Product Code: LXH
• UDI-Device Identifier: 10885862010704
• UDI-Public: 10885862010704
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/12/2020

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: 101-05-46
• Device Lot Number: 75322001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 02/12/2020
• 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