FDA Adverse Event Malfunction Summary report: N

COMPR WIRE Ø2.8 L200/10

MDR report key: 3002432 · Received March 13, 2013

Report

Report Number: 8030965-2013-00857
Event Type: Malfunction
Date Received: March 13, 2013
Date of Event: February 12, 2013
Report Date: February 15, 2013
Manufacturer: SYNTHES GMBH
Product Code: HWN
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. AN INVESTIGATION AND DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO PART OR LOT NUMBER WAS PROVIDED AND THE DEVICE WAS NOT RETURNED. PLACEHOLDER.

Description of Event or Problem · 1

A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFORMATION FROM A FACILITY IN (B)(6). IT WAS REPORTED THAT THE PERCUTANEOUS DEPTH GAUGE, DOES NOT SEEM TO MEASURE PROPERLY IN A 2.0 HOLE, POSSIBLY CAUSING THE 2.0 DRILL BIT TO BECOME BENT AT THE FUNNEL. WITH A 2.0 BORE HOLE, THE MEASURING DEVICE IS REPORTED TO BE TOO LONG IN THE CHANNEL, AS IT WAS OBSERVED THAT THE MEASURING DEVICE APPEARS TO GETS THINNER ON JUST THE LAST 3CM. THEREFORE, REPORTEDLY, IT IS DIFFICULT TO CATCH IN THE OPPOSITE CORTEX TO DETERMINE THE CORRECT LENGTH. THE COMPRESSION TOWER 3.5, RIPPED OUT OF THE PLATE HOLE DURING COMPRESSION, AND THE THREAD BECAME DAMAGED. THE SURGEON DID NOT USE A TORQUE LIMITER AS DESCRIBED IN SURGICAL TECHNIQUE. IN ADDITION, IT WAS NOTED THAT SMOKE HAS BEEN NOTICED DURING INSERTION OF THE COMPRESSION WIRE. A COMMENT WAS ADDED THAT WITHOUT COOLING, IT IS NOT POSSIBLE TO INSERT THE COMPRESSION WIRE WITHOUT SMOKE. THIS IS REPORT NUMBER 3 OF 3 FOR THE SAME EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
105056	COMPR WIRE Ø2.8 L200/10		HWN	SYNTHES GMBH

Patients

Seq	Age	Sex	Outcome	Treatment
1