FDA Adverse Event Malfunction Summary report: N

4.0MM CANNULATED SCREW LONG THREAD/46MM

MDR report key: 2872384 · Received December 13, 2012

Report

Report Number: 1719045-2012-01357
Event Type: Malfunction
Date Received: December 13, 2012
Date of Event: November 14, 2012
Report Date: November 14, 2012
Manufacturer: SYNTHES MONUMENT
Product Code: HWC
PMA / PMN Number: K963192
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO
Reporter Occupation: HEALTH PROFESSIONAL

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.

Additional Manufacturer Narrative · 1

DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. IMPLANTED APPROXIMATELY 2010 WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

Description of Event or Problem · 1

PATIENT WAS IMPLANTED WITH PLATE AND SCREWS IN APPROXIMATELY 2010. PATIENT WAS GOING IN THE MILITARY AND REQUESTED REMOVAL. PATIENT RETURNED TO OR ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. DURING THE REMOVAL TWO SCREWS STRIPPED AND ONE SCREW BROKE. SURGEON CORED AROUND THE SCREWS TO REMOVE THEM. SURGEON X-RAYED THE SITE AND NO FRAGMENTS OF HARDWARE REMAIN. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

Description of Event or Problem · 1

THIS IS REPORT 2 OF 2 FOR COMPLAINT # (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	4.0MM CANNULATED SCREW LONG THREAD/46MM	CANNULATED SCREW	HWC	SYNTHES MONUMENT

Patients

Seq	Age	Sex	Outcome	Treatment
1	19 YR			PLATE, SCREW