FDA Adverse Event Malfunction Summary report: N

SP2 IM ROD 400MM

MDR report key: 3123557 · Received May 22, 2013

Report

Report Number: 1818910-2013-17459
Event Type: Malfunction
Date Received: May 22, 2013
Date of Event: May 17, 2013
Report Date: May 17, 2013
Manufacturer: 1219655 DEPUY-RAYNHAM
Product Code: LXH
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EXAMINATION OF THE RETURNED DEVICE CONFIRMS INSTRUMENT BREAKAGE. A SEARCH OF THE COMPLAINTS DATABASES HAS IDENTIFIED A TREND OF THIS ISSUE. (B)(4) WAS IMPLEMENTED ON (B)(6) 2013 TO REMOVE THE CUSTOM 455 SS MATERIAL FROM DEPUY DRAWING (B)(4). A MEDICAL DEVICE CORRECTION NOTICE WAS DISTRIBUTED ON (B)(4) 2013 FOR SPECIFIC LOTS OF THE 966120 PRODUCT CODE. THE NOTICE INDICATED THAT DEPUY HAS IDENTIFIED THE POTENTIAL FOR THE SP2 IM ROD TO FAIL DUE TO FATIGUE WHEN EXCESS LEVERAGE IS APPLIED AT THE TIP. SEVERAL SURGICAL TECHNIQUES WERE UPDATED AND TECHNICAL POINTS WERE EMPHASIZED THAT MAY FURTHER REDUCE THE INCIDENCE OF TIP FRACTURE IN THE COMMUNICATION. THE ROOT CAUSE IS ATTRIBUTED TO DESIGN. MONITOR THROUGH TREND ANALYSIS.

Additional Manufacturer Narrative · 1

THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

Description of Event or Problem · 1

WHILE PREPARING THE INSTRUMENT, THE SURGEON FOUND OUT THAT THE IM ROD IS BROKEN.HE TOOK AN X-RAY AFTER THE SURGERY AND THE BROKEN PART IS NOT IN THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
225755	SP2 IM ROD 400MM	INSTRUMENTATION	LXH	1219655 DEPUY-RAYNHAM		H0409

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other