FDA Adverse Event Injury Summary report: N

DRILL BIT Ø2.5 L

MDR report key: 2862494 · Received December 10, 2012

Report

Report Number: 2520274-2012-03638
Event Type: Injury
Date Received: December 10, 2012
Date of Event: July 15, 2010
Report Date: July 26, 2010
Manufacturer: SYNTHES
Product Code: HTW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HSZ. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

Description of Event or Problem · 1

(B)(4) COMPLAINT HANDLING UNIT REPORTED, DRILL BIT WAS BROKEN WHILE DRILLING. THE SURGEON DRILLED AT APPROX SACROILIAC BY OSCILLATING FUNCTION OF THE POWER TOOL. THE DRILL BIT BROKE BEFORE CORTEX WAS PENETRATED. DRILLED DEPTH WAS 40-50MM, BROKEN PART WAS LEFT IN THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DRILL BIT Ø2.5 L		HTW	SYNTHES

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	DRILL BIT 02.5 L180/155 2FLUTE