FDA Adverse Event Malfunction Summary report: N

MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

MDR report key: 2873419 · Received December 14, 2012

Report

Report Number: 1030489-2012-02811
Event Type: Malfunction
Date Received: December 14, 2012
Date of Event: November 16, 2012
Report Date: November 16, 2012
Manufacturer: MSD BARTLETT MFG
Product Code: LXH
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

VISUALLY CONFIRMED APPROXIMATELY ~4MM OF THE INSTRUMENT TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. INSPECTION OF THE SHAFT DIAMETER AND MATERIAL HARDNESS CONFIRMED CONFORMANCE TO PRINT SPECIFICATION. FRACTURE SURFACE ANALYSIS OF BOTH INSTRUMENTS IDENTIFIED A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL MOVEMENT, CONSISTENT WITH TORSIONAL OVERLOAD. THE ABOVE FINDINGS ARE CONSISTENT WITH TORSIONAL OVERLOAD.

Additional Manufacturer Narrative · 1

CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

(B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SURGICAL PROCEDURE AT L5-S. ON 7-8 YEARS POST-OP THE PATIENT UNDERWENT A REMOVAL SURGERY DUE TO COMPLETION OF BONE UNION. DURING REMOVAL OF SCREWS, THE TIP OF THE DRIVER BROKE OFF. THE FRAGMENT WAS STUCK IN THE SCREW POST. THE SURGEON WAS ABLE TO REMOVE THE SCREW USING ANOTHER INSTRUMENT SUCCESSFULLY. NO FRAGMENT WAS LEFT IN THE PATIENT. NO PATIENT INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MANUAL ORTHOPEDIC SURGICAL INSTRUMENT	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	LXH	MSD BARTLETT MFG	NA	JM04D030

Patients

Seq	Age	Sex	Outcome	Treatment
1	00051 YR