FDA Adverse Event Malfunction Summary report: N

LCP DRILL BIT 2.8 W/STOP L165 2FLUTE

MDR report key: 2760739 · Received September 20, 2012

Report

Report Number: 8030965-2012-00869
Event Type: Malfunction
Date Received: September 20, 2012
Date of Event: August 14, 2012
Report Date: August 23, 2012
Manufacturer: SYNTHES GMBH
Product Code: HTW
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE MEASURABLE DIMENSIONS OF THE BROKEN DRILL BIT WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. THE DRILL BIT WAS BROKEN DUE TO MECHANICAL OVERLOADING DURING USE AND ASSUMES THAT HEAVY LOADINGS IN LATERAL DIRECTION MAY HAVE CAUSED THE BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

Additional Manufacturer Narrative · 1

THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

Description of Event or Problem · 1

A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: THE SURGEON USED PHILOS, FOR THE PATIENT, DUE TO PROXIMAL FRACTURE OF HUMERAL. SURGEON DRILLED IN DISTAL HOLE WITH GLIDING BLOCK AND THE DRILL BIT BROKE. THE BROKEN FRAGMENT COULD NOT BE RETRIEVED; BROKEN PIECE REMAINS IN THE PATIENT, SURGEON DOES NOT HAVE PLANS TO REMOVE THE BROKEN DRILL BIT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LCP DRILL BIT 2.8 W/STOP L165 2FLUTE	LCP DRILL BIT	HTW	SYNTHES GMBH		2299945

Patients

Seq	Age	Sex	Outcome	Treatment
1	40 YR