MAUDE Adverse Event Report: EXACTECH, INC TORQUE DEFINING SCREW KIT

Lot Number 4627659

Device Problems Component Falling (1105); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

Pending device return and engineering evaluation.

Event Description

After torquing the screw, when pulling the driver out, the head of the screw fell into the wound site and had to be retrieved.

Manufacturer Narrative

It is noted that only qualified surgeons who are fully knowledgeable about all aspects of surgical technique and are fully trained to use the system and instrumentation are to use these devices.The most likely cause of the driver failing to retain the screw appears to be due to the surgeon not fully pushing the driver completely over the poly plugs.This device is used for treatment not diagnosis.

• Brand Name: TORQUE DEFINING SCREW KIT
• Type of Device: SCREW KIT
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6456225
• MDR Text Key: 71598986
• Report Number: 1038671-2017-00213
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/17/2021
• Device Lot Number: 4627659
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR