2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/2H SHAFT/RT-STER

Report

Report Number: 1000562954-2014-10094
Event Type: Malfunction
Date Received: June 10, 2014
Date of Event: April 10, 2014
Report Date: April 11, 2014
Manufacturer: SYNTHES MEZZOVICO
Product Code: HRS
PMA / PMN Number: PK092556
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL NARRATIVE: DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE HWC. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

DEVICE REPORT FROM SYNTHES (B)(4) , REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE USED FOR A DISTAL RADIUS FRACTURE CASE. THE SCREW WAS INSERTED INTO THE ANGLED SCREW HOLE TOWARD THE RADIAL STYLOID PROCESS AT THE MOST DISTAL RADIAL SIDE USING THE TORQUE LIMITER. THE SURGEON FOUND THAT THE TORQUE LIMITER WAS SPINNING AND THE SCREW COULD NOT BE LOCKED. HE DIDN¿T HEAR A CLICKING SOUND OF THE TORQUE LIMITER, SO HE USED A SHORTER SCREW AS A SUBSTITUTE AND FINISHED THE OPERATION. DUE TO THE INCIDENT, THE OPERATION WAS EXTENDED FOR 15 MINUTES, THERE WAS NO PATIENT HARM. THIS REPORT IS 2 OF 3 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
337740	2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/2H SHAFT/RT-STER	PLATE,FIXATION,BONE	HRS	SYNTHES MEZZOVICO		8839789

Patients

Seq	Age	Sex	Outcome	Treatment
1