FDA Adverse Event Malfunction Summary report: N

2520274-2014-00409

MDR report key: 3605405 · Received February 4, 2014

Report

Report Number: 2520274-2014-00409
Event Type: Malfunction
Date Received: February 4, 2014
Date of Event: January 12, 2014
Report Date: January 12, 2014
Manufacturer: SYNTHES USA
Product Code: HWC
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. PLACEHOLDER.

Description of Event or Problem · 1

IT WAS REPORTED DURING A LATERAL ENTRY FEMORAL NAIL (LEFN) PROCEDURE, THE SURGEON HAD A PROBLEM WITH TWO OF THE LATERAL ENTRY FEMORAL NAIL INSTRUMENTS. WHEN INSERTING PART NUMBER/LOT NUMBER 03.010.063/4933987 (12.0MM/8.0MM PROTECTION SLEEVE 188MM) IT WOULD NOT GO THROUGH PART NUMBER/LOT NUMBER 03.010.045/1768650 (STANDARD INSERTION HANDLE). A RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) SET WAS AVAILABLE BUT THE SURGEON WAS UNABLE TO INSERT AN OBLIQUE LOCKING SCREW AND A SECOND PROBLEM OCCURRED WITH THE SAME 03.010.043 TROCAR. WHEN THE SCREW WENT THROUGH THE TROCAR, IT WAS UNABLE TO EXIT THE SIDE CLOSEST TO THE BONES. THE SURGEON HAD TO REMOVE THE SCREW AND USE THE SCREW FROM THE RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) SET TO SUCCESSFULLY INSERT THE SCREW. THE SURGERY WAS PROLONGED 15 MINUTES. NO FURTHER INFORMATION WAS PROVIDED. PATIENT STATUS/OUTCOME FOLLOWING THE PROCEDURE WAS NOT PROVIDED. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
71581			HWC	SYNTHES USA

Patients

Seq	Age	Sex	Outcome	Treatment
1