FDA Adverse Event Malfunction Summary report: N

APPLICATOR INNER SHAFT

MDR report key: 3190005 · Received June 26, 2013

Report

Report Number: 8030965-2013-03995
Event Type: Malfunction
Date Received: June 26, 2013
Date of Event: March 8, 2012
Report Date: March 22, 2012
Manufacturer: SYNTHES GMBH
Product Code: LXH
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AU
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 REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE EVALUATION FOUND THAT THE KNOB OF THE APPLICATOR INNER SHAFT HAS IN FACT BROKEN OFF AT THE BACK. WE PRESUME THAT THE MECHANICAL LOAD WAS TOO HIGH AND CAUSED THE BREAKAGE OF THE END. THE PIECE THAT HAS BROKEN OFF IS STUCK IN THE KNOB AND WOULD DAMAGE THE INTERIOR OF THE KNOB IF TAKEN OUT.

Description of Event or Problem · 1

TIP OF INNERSHAFT BROKE OFF. THE BALL BROKE OFF AT THE UPPER END OF THE INNER SHAFT AND GOT STUCK IN THE KNOB. THIS IS 1 OF 1 REPORT FOR EVENT (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
291626	APPLICATOR INNER SHAFT		LXH	SYNTHES GMBH		7546227

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR