MAUDE Adverse Event Report: EXACTECH, INC. NOV 6.5MM HEX DRIVER ARTICULATING; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Model Number	NOV 6.5MM HEX DRIVER ARTICULATING
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the tip of the driver shaft broke off during tightening of the hip screw.This caused no delay, patient was not affected, and this surgery continued as normal.Patient is in stable condition.The device will be returned.
Additional Manufacturer Narrative
After further review of additional information received the following sections g4, g7, h2, h3 and h6 have been updated accordingly.(h3) the evaluation noted that revision reported was likely the result of applying torque greater than the yield strength of the material, possibly secondary to contributions from either hard bone or insufficient drilling depth during bone preparation, that resulted in the shearing off of the driver hex tip.The most probable root cause associated with the reported event of "broken / non-functional" is associated with small pieces of the device breaking off unexpectedly.Section d9: device available for evaluation.

• Brand Name: NOV 6.5MM HEX DRIVER ARTICULATING
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11438848
• Report Number: 1038671-2021-00096
• Device Sequence Number: 3763022
• Product Code: JDI
• UDI-Device Identifier: 10885862038661
• UDI-Public: 10885862038661
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/06/2021

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 Model Number: NOV 6.5MM HEX DRIVER ARTICULATING
• Device Catalogue Number: 181-65-02
• Device Lot Number: 154271001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1