AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX

Report

Report Number: 2520274-2015-14820
Event Type: Injury
Date Received: July 7, 2015
Date of Event: June 24, 2015
Report Date: June 26, 2015
Manufacturer: SYNTHES USA
Product Code: FZX
PMA / PMN Number: PEXEMPT
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(6). DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

UPDATED INFORMATION RECEIVED ON JULY 14, 2015 INDICATED THAT THE DISTAL NAIL BLOCKS WERE MANUALLY USED. A SURGICAL DELAY OF FORTY-FIVE (45) MINUTES WAS NOTED. THIS REPORT IS 1 OF 3 FOR (B)(4).

Description of Event or Problem · 1

DEVICE REPORT FROM SYNTHES EU REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE DRILL BIT CLASHED WITH THE NAIL WHEN THE SURGEON WAS DOING THE LOCKING OF THE EXPERT NAIL FOR THIS THE SURGEON HAD THAT TO DO STRENGTH TO DO THE LOCKING OF HOLES NAIL. THERE WAS NO PROLONGATION OF SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
438942	AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX	GUIDE	FZX	SYNTHES USA

Patients

Seq	Age	Sex	Outcome	Treatment
1	17 YR		Required Intervention