FDA Adverse Event Malfunction Summary report: N

1.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 4MM

MDR report key: 3073165 · Received April 23, 2013

Report

Report Number: 1719045-2013-10775
Event Type: Malfunction
Date Received: April 23, 2013
Date of Event: June 12, 2012
Report Date: June 12, 2012
Manufacturer: SYNTHES USA
Product Code: HRS
PMA / PMN Number: K912932
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER HEALTH CARE 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. 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.

Additional Manufacturer Narrative · 1

SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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)(4).

Description of Event or Problem · 1

CONSULTANT REPORTS DURING ORBITAL RIM ZYGOMA PROCEDURE, THREE (3) SCREW HEADS BROKE OFF DURING INSERTION. ALL PIECES WERE RETRIEVED. NO HARM TO PATIENT. NO ADDITIONAL INFORMATION AVAILABLE. THIS IS 1 OF 3 REPORT FOR EVENT (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
174804	1.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 4MM		HRS	SYNTHES USA

Patients

Seq	Age	Sex	Outcome	Treatment
1	26 YR