FDA Adverse Event Malfunction Summary report: N

D/M ONE-SIDED CABLE TENSIONER

MDR report key: 2844982 · Received October 24, 2012

Report

Report Number: 2249697-2012-02061
Event Type: Malfunction
Date Received: October 24, 2012
Date of Event: October 1, 2012
Report Date: October 1, 2012
Manufacturer: STRYKER ORTHOPAEDICS MAHWAH
Product Code: LXH
PMA / PMN Number: NA
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE ROOT CAUSE WAS DETERMINED TO BE IMPROPER CLEANING AND LUBRICATION BETWEEN USES. VISUAL INSPECTION OF THE RETURNED DEVICES DETERMINED THEY SHOWED SIGNS OF IMPROPER CLEANING AND LACK OF LUBRICATION, WHICH LED TO THE TENSIONING JAWS BECOMING CORRODED. THE CORROSION PREVENTS THE JAWS FROM FUNCTIONING PROPERLY. DEVICE HISTORY REVIEW DETERMINED ALL DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW FOUND ONE OTHER EVENT FOR THE LOT. THERE HAVE BEEN OTHER EVENTS FOR THE CATALOG NUMBER. THE ROOT CAUSE WAS DETERMINED TO BE FAILURE TO PROPERLY CLEAN AND LUBRICATE THE DEVICE. A REVIEW OF THE DEVICE PACKAGE INSERT REVEALED THE FOLLOWING RELATED TO LUBRICATION OF THE DEVICE: INSTRUMENTS WITH ARTICULATING SURFACES MUST BE TESTED FOR MOVEMENT. A MOIST HEAT COMPATIBLE, MEDICAL GRADE LUBRICANT SHOULD BE APPLIED TO ALL ARTICULATING JOINTS PRIOR TO STERILIZATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT 2 DALL MILES TENSIONERS FAILED TO TENSION, WOULD NOT TIGHTEN DOWN. THIS WAS REPORTED TO REP BY THE HOSPITAL AFTER CASE PERFORMED ON (B)(6) 2012.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	D/M ONE-SIDED CABLE TENSIONER	INSTRUMENT	LXH	STRYKER ORTHOPAEDICS MAHWAH	NA	TACG91J

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other