BIT, DRILL

MDR report key: 3974034 · Received August 1, 2014

Report

Report Number: 1030489-2014-03386
Event Type: Malfunction
Date Received: August 1, 2014
Date of Event: July 4, 2014
Report Date: July 4, 2014
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: HTW
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

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

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION : PRODUCT ANALYSIS : THE CANNULATED DRILL IS FRACTURED AT THE INTERSECTION BETWEEN THE DRILL TIP AND THE DRIVING SHAFT. THE RAPID CROSS SECTIONAL AREA REDUCTION OF THIS TRANSITION CREATES A POTENTIAL STRESS CONCENTRATION UNDER BENDING LOADS OR LATERAL IMPACT, SUCH DURING OFF-AXIS INSTRUMENT USAGE. OPTICAL EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED A QUASI-BRITTLE FRACTURE WITH RIVERLINES WHICH APPEAR TO FLOW TOWARD THE CENTER OF THE PART, WITH APPARENT SHEAR LIP AT ID OF THE SHAFT. DIRECTION OF FRACTURE PROPAGATION AND INTERNAL SHEAR LIP SUGGEST BEND STRESS OVERLOAD.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT WITH A TRAUMATIC ODONTOID FRACTURE UNDERWENT AN ANTERIOR CERVICAL FUSION AT C2. AT THE TIME OF DRILLING, A TIP OF A CANNULATED DRILL BIT BROKE OFF. A KOCHER WAS USED TO REMOVE THE BROKEN PART THAT PROTRUDED FROM THE BONE SURFACE. THE SURGICAL TIME WAS EXTENDED DUE TO THE INCIDENT LESS THAN 15 MINUTES. NO PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
451081		BIT, DRILL	HTW	MEDTRONIC SOFAMOR DANEK USA, INC	NA	NG13K011

Patients

Seq	Age	Sex	Outcome	Treatment
1				KOSHER