FDA Adverse Event Malfunction Summary report: N

VA LOCKSCR Ø2.4 SELF-TAP L12 TAN

MDR report key: 3175097 · Received June 18, 2013

Report

Report Number: 8030965-2013-03524
Event Type: Malfunction
Date Received: June 18, 2013
Date of Event: January 26, 2012
Report Date: January 27, 2012
Manufacturer: SYNTHES GMBH
Product Code: HWC
PMA / PMN Number: K103243
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). A REQUEST FOR THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN MADE. THE INVESTIGATION OF THE RETURNED LOCKING SCREW SHOWS FULL CONFORMITY TO THE SPECIFICATION. THIS SCREW IS CLEARLY FAULTLESS AND IN COMPLETE FUNCTION.

Additional Manufacturer Narrative · 1

SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE 510K #: K103243. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

Description of Event or Problem · 1

DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, THE SCREW THAT WAS BEING USED WENT COMPLETELY THROUGH THE HOLE OF THE PLATE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
275616	VA LOCKSCR Ø2.4 SELF-TAP L12 TAN		HWC	SYNTHES GMBH		7651771

Patients

Seq	Age	Sex	Outcome	Treatment
1