FDA Adverse Event Malfunction Summary report: N

SNAPOFF SCREW 2.0 X 12MM

MDR report key: 14112561 · Received April 14, 2022

Report

Report Number: 3012966183-2022-00010
Event Type: Malfunction
Date Received: April 14, 2022
Date of Event: March 14, 2022
Report Date: April 14, 2022
Manufacturer: TYBER MEDICAL
Product Code: HWC
PMA / PMN Number: K133842
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

IMPLANT DIMENSIONS MET DESIGN SPECIFICATIONS. ENGINEERING TEST REPORT TR-201602 EVALUATED THE SNAP-OFF DESIGN AND CONFIRMED ACCEPTANCE OF DESIGN AND FUNCTIONAL CRITERIA. DEVICE WAS EVALUATED BY ENGINEERING UPON RETURN. IMPLANT WAS MEASURED TO BE WITHIN DESIGN TOLERANCES, SPECIFICALLY FOR THE SNAP-OFF REGION OF THE DEVICE. DHR WAS REVIEWED TO FIND NO NONCONFORMANCES ASSOCIATED WITH THIS LOT OF IMPLANTS. LOT MET RELEASE REQUIREMENTS. NO NONCONFORMANCES IN THE LOT ARE RELATED TO THE NATURE OF THE COMPLAINT.

Description of Event or Problem · 0

THE DOCTOR NOTED THAT HE HAD ATTEMPTED TO IMPLANT 3 DIFFERENT SNAPFIX SCREWS (2.0X12MM - FSS 212). AFTER HAVING SOME DIFFICULTY WITH GETTING THE FIRST SNAPFIX SCREW TO "SNAP OFF", THE DOCTOR WAS FINALLY ABLE TO SNAP IT OFF AND IMPLANT IT. THE DOCTOR ATTEMPTED TO INSERT A SECOND SNAPFIX SCREW, AND WAS UNABLE TO SNAP OFF THE SCREW. AT THIS POINT, IT WAS DISCOVERED THAT THE CORTEX OF THE METATARSAL WAS BROKEN THROUGH. THE DOCTOR ATTEMPTED TO INSERT A THIRD SNAPFIX SCREW, AND WAS AGAIN UNABLE TO SNAP OFF THE SCREW. (THEREFORE, THE DOCTOR COULD NOT SNAP OFF A TOTAL OF 2 OF THE 3 SNAPFIX SCREWS). THE CASE WAS ABLE TO BE SUCCESSFULLY COMPLETED USING SIMILAR SNAP-OFF SCREWS FROM ANOTHER COMPANY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1639371	SNAPOFF SCREW 2.0 X 12MM	SCREW	HWC	TYBER MEDICAL	FSS-212	226421

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Other