FDA Adverse Event Malfunction Summary report: N

SUMMIT 2.0MM HEX DRIVER SHAFT

MDR report key: 1013835 · Received March 14, 2008

Report

Report Number: 1526439-2008-00068
Event Type: Malfunction
Date Received: March 14, 2008
Date of Event: February 21, 2008
Manufacturer: DEPUY SPINE, INC.
Product Code: LXH
PMA / PMN Number: NA
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

NO CONCLUSIONS CAN BE MADE AT THIS TIME. EVENTS OF THIS NATURE CAN RESULT FROM EXCESSIVE FORCE BEING APPLIED TO THE DEVICE. THE INSTRUMENT IS MADE OF STAINLESS STEEL AND ALTHOUGH IT IS NOT IMPLANT GRADE, IT IS CONTROLLED IN ITS MANUFACTURING AND SPECIFICATIONS. IN PARTICULAR, IT IS RESISTANT TO CORROSION IN A VARIETY OF ENVIRONMENTS, INCLUDING BLOOD. FURTHERMORE, THE SPECIFICATION FOR THE PRODUCT REQUIRES PASSIVATION, WHICH FURTHER INCREASES THE MATERIAL'S RESISTANCE TO CORROSION. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED. A FOLLOW UP MEDWATCH REPORT WILL BE FILED IF THE EVALUATION OF THE RETURNED DEVICE REVEALS SOMETHING OTHER THAN THAT WHICH IS STATED ABOVE.

Description of Event or Problem · 1

INTERNATIONAL AFFILIATE REPORTS THE TIP OF THE HEX DRIVER SHAFT BROKEN OFF IN THE SET SCREW OF A CROSS-CONNECTOR ASSEMBLY WHEN THE TORQUE LIMITING DRIVER USED IN THE PROCEDURE FAILED TO RELEASE. THE BROKEN TIP COULD NOT BE RETRIEVED AND REMAINS IN THE IMPLANTED CROSS-CONNECTOR. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AS A PORTION OF THE HEX DRIVER SHAFT REMAINS IN THE IMPLANTED DEVICE, A MEDWATCH REPORT IS BEING FILED TO DOCUMENT THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SUMMIT 2.0MM HEX DRIVER SHAFT	ORTHOPAEDIC MANUAL SURGICAL INSTRUMENT	LXH	DEPUY SPINE, INC.	NA	E0705

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK			SUMMIT TORQUE LIMITING DRIVER\| SUMMIT CROSS CONNECTOR ASSEMBLY