FDA Adverse Event Malfunction Summary report: N

VA-LCP-2-COLUMN DRP2.4 VOLAR LE SHAFT 2H

MDR report key: 2893772 · Received January 2, 2013

Report

Report Number: 8030965-2013-00008
Event Type: Malfunction
Date Received: January 2, 2013
Date of Event: November 30, 2012
Report Date: December 4, 2012
Manufacturer: SYNTHES GMBH
Product Code: HRS
PMA / PMN Number: K083694
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

Description of Event or Problem · 1

DEVICE REPORT FROM (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A DISTAL RADIUS FRACTURE PROCEDURE, THE SCREW WOULD NOT LOCK. THE SURGEON CHOSE VARIABLE ANGLE (VA) MODE. THE SURGEON INSERTED THE VA LOCKING SCREWS IN A POSITIONING HOLE AFTER DRILLING. REPORTEDLY THE SURGEON COULD NOT LOCK THE VA LOCKING SCREW IN THE DISTAL ROW SECOND ULNA HOLE. HE STOPPED INSERTING SCREW CLOSE TO PENETRATION. HE PLANED THIS SCREW RESTED IN PATIENT BODY. IT WAS REPORTED HE HAD A PROBLEM WITH THE SCREW DUE TO LENGTH. THE SURGEON THEN CHANGED AND INSERTED OTHER NEW SCREW. THE NEW SCREW COULD BE LOCKED IN THIS HOLE. HE CHOSE VA MODE, HE USED TORQUE LIMITER, 0.8NM, IN LOCK. THIS IS 2 OF 2 REPOTS FOR THE SAME EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
732	VA-LCP-2-COLUMN DRP2.4 VOLAR LE SHAFT 2H	VA LCP PLATE	HRS	SYNTHES GMBH		3797861

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR			SCREW