FDA Adverse Event Malfunction Summary report: N

TRIDENT POLYETHYLENE RMVL TOOL

MDR report key: 3852195 · Received June 5, 2014

Report

Report Number: 0002249697-2014-02136
Event Type: Malfunction
Date Received: June 5, 2014
Date of Event: May 12, 2014
Report Date: May 16, 2014
Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
Product Code: LXH
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN (B)(4) OTHER EVENT REPORTED FOR THE REPORTED MANUFACTURING LOT THE DAMAGED DEVICE WAS DISCOVERED DURING INSPECTION; THERE WAS NO SURGICAL PROCEDURE ASSOCIATED WITH THE REPORTED EVENT. THIS EVENT MEETS THE DEFINITION OF PREVENTIVE MAINTENANCE; NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

Additional Manufacturer Narrative · 1

WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

WHEN THE IN-COMING INSPECTION BY DISTRIBUTION CENTER STUFF, THE TIP OF THE DEVICE HAD BROKEN. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014 INDICATED THAT THIS EVENT OCCURRED DURING REVISION SURGERY.

Description of Event or Problem · 1

WHEN THE IN-COMING INSPECTION BY DISTRIBUTION CENTER STUFF, THE TIP OF THE DEVICE HAD BROKEN. ADDITIONAL INFORMATION RECEIVED ON MAY 21, 2014 INDICATED THAT THIS EVENT OCCURRED DURING REVISION SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
329736	TRIDENT POLYETHYLENE RMVL TOOL	INSTRUMENT	LXH	STRYKER ORTHOPAEDICS-MAHWAH		F5T10803

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other