FDA Adverse Event Malfunction Summary report: N

BOLT CUTTING HEAD Ø5 LONG CUTTING-H 2 F/

MDR report key: 3191925 · Received June 27, 2013

Report

Report Number: 8030965-2013-03647
Event Type: Malfunction
Date Received: June 27, 2013
Date of Event: November 4, 2011
Report Date: November 29, 2011
Manufacturer: SYNTHES GMBH
Product Code: HXZ
PMA / PMN Number: EXEMPT
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. ADDITIONAL PRODUCT CODE(S) FOR THIS REPORT INCLUDE HTZ, AND FZT. THE INVESTIGATION HAS SHOWN THAT THE BOTTOM OF THE CUTTING HEAD IS INDEED BROKEN OFF. THE REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED THAT THE PRESENT INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE EXACT REASON OF THIS DAMAGE IS UNDETERMINED. PLEASE NOTE IT IS VERY IMPORTANT THAT THE SCHANZ SCREW IS POSITIONED CORRECTLY BEFORE CUTTING AND THAT VERY FAST CUTTING-PROCEDURES MAY LEAD TO A SHORT TIME OVERLOADING RESULTING IN THE BREAKAGE OF THE BOTTOM OF THE CUTTING HEAD. IN ADDITION THIS INSTRUMENT IS SUBJECTED TO COMMON WEAR AND TEAR AND AS SOON AS THE CUTTING PROCEDURE GETS HARDER IT MAY BE INDICATED THAT THE DEVICE SHOULD BE REPLACED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

Description of Event or Problem · 1

CUTTER HEAD IS BROKEN OFF. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
293531	BOLT CUTTING HEAD Ø5 LONG CUTTING-H 2 F/		HXZ	SYNTHES GMBH		1157772

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR