FDA Adverse Event Malfunction Summary report: N

LAG SCREWDRIVER 380X110MM

MDR report key: 1692674 · Received May 13, 2010

Report

Report Number: 9610622-2010-00204
Event Type: Malfunction
Date Received: May 13, 2010
Date of Event: April 19, 2010
Report Date: April 26, 2010
Manufacturer: STRYKER OSTEOSYNTHESIS KIEL
Product Code: HXX
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: VISUAL EXAMINATION- THE FIRST WINDING OF THE THREAD OF THE INNER TUBE IS DEFORMED AND SHOWS TRACES OF CROSS THREADING. REVIEW OF DEVICE HISTORY RECORD (DHR)-INSPECTION RECORDS. A REVIEW OF THE DHR FOR THE LAG SCREWDRIVER (LOT CODE K533502) REVEALED NO DISCREPANCIES. THE ITEM WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION AND HAS BEEN IN USE FOR A LONGER TIME (APPROXIMATELY 2.5), WE PRE-SUPPOSE THAT THE LAG SCREWDRIVER HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. DEVIATIONS IN THE MANUFACTURING DOCUMENTS WERE NOT FOUND. THE FIRST WINDING OF THE INNER TUBE IS DAMAGED- PROBABLY DUE TO A WRONG USE OF THE ITEM OR OBLIQUE ADAPTING. DUE TO THE FOUND DAMAGE A CORRESPONDING LAG SCREW COULD NOT BE CONNECTED WITH THE INNER TUBE. EVALUATION REVEALED THAT THE REPORTED EVENT IS MOST LIKELY LINKED TO USER ERROR CONTRIBUTED BY THE DESIGN OF THE DEVICE.

Description of Event or Problem · 1

IT WAS REPORTED FROM CENTRAL STERILE SERVICES THAT THE CONNECTION BETWEEN THE LAG SCREWDRIVER AND THE LAG SCREW IS TOO LOOSE. THE SURGERY WAS FINALIZED WITH ANOTHER LAG SCREWDRIVER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LAG SCREWDRIVER 380X110MM	INSTRUMENT	HXX	STRYKER OSTEOSYNTHESIS KIEL	NA	K533502

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other