FDA Adverse Event Malfunction Summary report: N

MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

MDR report key: 2860335 · Received December 6, 2012

Report

Report Number: 1030489-2012-02601
Event Type: Malfunction
Date Received: December 6, 2012
Date of Event: November 7, 2012
Report Date: November 7, 2012
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: LXH
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

VISUALLY CONFIRMED APPROXIMATELY ~3MM OF THE INSTRUMENT TIPS HAVE BEEN BROKEN OFF AND NOT RETURNED FOR ANALYSIS. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT DUCTILE FRACTURE WITH CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD, DIMENSIONAL INSPECTION OF THE TIP DIAMETER AND MATERIAL HARDNESS CONFIRMS CONFORMANCE TO PRINT SPECIFICATION. THE ABOVE FINDINGS ARE CONSISTENT WITH TORSIONAL OVERLOAD.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

(B)(4): THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. AFTER TIGHTENING THE SETSCREW OF THE DOMINO THE SURGEON WANTED TO CHECK THAT THE SCREW WAS ENGAGED IN THE ROD. WHEN TRYING TO LOOSEN THE SET SCREW, THE TIP OF THE DRIVER SHEARED OFF IN THE SETSCREW. NO PATIENT COMPLICATIONS WERE REPORTED

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MANUAL ORTHOPEDIC SURGICAL INSTRUMENT	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	LXH	MEDTRONIC SOFAMOR DANEK USA, INC	NA	PR05G009

Patients

Seq	Age	Sex	Outcome	Treatment
1				SCREW