MAUDE Adverse Event Report: EXACTECH, INC. 3" DRILL BIT, MOD. HEX 2 PACK; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	3" DRILL BIT, MOD. HEX 2 PACK
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the drill bit bent during insertion through the proximal tibial cut guide.The guide directs the pin toward the medial cortex of the tibia and the bone is extremely hard which most likely cause the pin to bend and cause a corticotomy.The patient was discharged as planned.The device is not available for evaluation as it was mixed in with the other drills used during the surgery.
Additional Manufacturer Narrative
(h3) the evaluation noted that revision reported was likely the result of both the placement of the tibial cut guide and the patient¿s hard bone, which allowed the drill bit to bend and ultimately resulted in a corticotomy.The most probable root cause for the reported event is associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device and problem associated with incorrect assembly of the device or constituents by the users.

• Brand Name: 3" DRILL BIT, MOD. HEX 2 PACK
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11229249
• Report Number: 1038671-2021-00017
• Device Sequence Number: 3446333
• Product Code: JWH
• UDI-Device Identifier: 10885862045621
• UDI-Public: 10885862045621
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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 Expiration Date: 01/13/2013
• Device Model Number: 3" DRILL BIT, MOD. HEX 2 PACK
• Device Catalogue Number: 201-78-89
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 02/23/2021
• 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: Required Intervention; Disability