FDA Adverse Event Malfunction Summary report: N

STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

MDR report key: 3073090 · Received April 23, 2013

Report

Report Number: 8030965-2013-10971
Event Type: Malfunction
Date Received: April 23, 2013
Date of Event: June 11, 2012
Report Date: June 11, 2012
Manufacturer: SYNTHES USA
Product Code: JDQ
PMA / PMN Number: K110789
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. 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. MANUFACTURING SITE ADDRESS IS UNKNOWN. (B)(4). PLACEHOLDER.

Description of Event or Problem · 1

CONSULTANT REPORTS SURGEON USING ZIPFIX IN THE OR FOR THE FIRST TIME, ZIP TIE BROKE WHILE BEING CUT. REMAINING FOUR (4) ZIP TIES PLACED SUCCESSFULLY. STERNUM APPEARED STABLE. PROCEDURE COMPLETED WITH NO HARM TO PATIENT. THIS IS 1 OF 1 REPORT FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
173260	STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK		JDQ	SYNTHES USA

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR