FDA Adverse Event Malfunction Summary report: N

VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA

MDR report key: 3011346 · Received March 19, 2013

Report

Report Number: 8030965-2013-01019
Event Type: Malfunction
Date Received: March 19, 2013
Date of Event: January 8, 2013
Report Date: February 18, 2013
Manufacturer: SYNTHES GMBH
Product Code: HRS
PMA / PMN Number: K092556
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

Narratives

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. ADDITIONAL PRODUCT CODE - HWC.

Description of Event or Problem · 1

DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT SUFFERED FROM FRACTURE OF THE DISTAL RADIUS. PATIENT WAS IMPLANTED WITH VA LCP 2 COLUMN DRP2.4 VOLAR NARROW PLATE AND SIX VA LOCKING SCREWS ON (B)(6) 2013. WHEN SURGEON WAS INSERTING THE MOST DISTAL SCREW WHILE USING A GUIDE BLOCK, THE VA LCP WOULD NOT LOCK. SURGEON INSERTED THE SCREW LOCATED IN THE SECOND LINE OF THE DISTAL SIDE AND DECIDED THERE WERE NO PROBLEMS AND THE PROCEDURE WAS COMPLETED. SURGEON CHECKED X-RAY IMAGES, AND FOUND THAT THE MOST DISTAL SCREW PENETRATED THE PLATE. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
114094	VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA		HRS	SYNTHES GMBH		7991272

Patients

Seq	Age	Sex	Outcome	Treatment
1