FDA Adverse Event Malfunction Summary report: N

BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM.1.2X5MM

MDR report key: 1850343 · Received September 22, 2010

Report

Report Number: 8010177-2010-00333
Event Type: Malfunction
Date Received: September 22, 2010
Date of Event: August 24, 2010
Report Date: August 24, 2010
Manufacturer: STRYKER OSTEOSYNTHESIS FREIBURG
Product Code: JEY
PMA / PMN Number: K022185
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

BECAUSE THE AFFECTED SCREW HEADS WERE NOT RETURNED FOR EVALUATION THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON STATISTICAL EVALUATION NO INDICATION WAS FOUND FOR ANY DEVICE RELATED ISSUE. THE COMPLAINT IS ADDED TO THE TREND. POTENTIAL ROOT CAUSES FOR A SCREW FRACTURE ARE: BONE WAS HARD WITH RESULTING HIGH TORQUE. APPLICATION OF UNINTENDED LOADS (E.G. BECAUSE OF AN IMPROPER PILOT HOLE - NOT DEEP ENOUGH, OBLIQUE, ECCENTRIC, INADEQUATE SENSITIVE TIGHTENING OF THE SCREW DURING INSERTION). INADEQUATE SCREWDRIVER/SCREW HEAD CONNECTION (NOT ALIGNED IN THE VERTICAL DIRECTION, INADEQUATE AXIAL ALIGNMENT AND CONTACT). COLLISION WITH OTHER IMPLANT OR INSTRUMENT.

Description of Event or Problem · 1

"WHEN TIGHTENING THE SCREW DURING A CASE THE HEAD OF THE SCREW CAME OFF ON TWO DIFFERENT SCREWS BACK TO BACK."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM.1.2X5MM	IMPLANT	JEY	STRYKER OSTEOSYNTHESIS FREIBURG	NA	0

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK