INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH

Report

Report Number: 2520274-2014-12250
Event Type: Injury
Date Received: July 1, 2014
Date of Event: May 13, 2014
Report Date: June 3, 2014
Manufacturer: SYNTHES USA
Product Code: HWE
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS FOR AN UNKNOWN POWER TOOL/UNKNOWN LOT. IMPLANT/EXPLANT DATE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. DEVICE WAS 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.

Description of Event or Problem · 1

DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON WANTED TO CHANGE THE DIRECTION OF THE PLATE (ROTATION TO LOCKING) DURING A VALGISTATION OSTEOTOMY OF THE RIGHT KNEE BUT IT WAS IMPOSSIBLE TO UNLOCK THE SCREW. THE SCREW EXTRACTOR BROKE DURING THE ATTEMPTED LOOSENING. THE SCREW HAD TO BE CUT TO REMOVE THE MATERIAL. OSTEOTOMY BEGAN WITH THE SAW AND FINISHED WITH THE POWER TOOL. THE PLATE HAD TO BE CHANGED AS WELL DUE TO NOT BEING ABLE TO UNLOCK THE SCREW. NO PIECE WAS LEFT IN THE PATIENT. THE PATIENT WAS GIVEN AN EXTRA DOSE OF ANTIBIOTIC. THERE WAS A SURGICAL DELAY OF MORE THAN THIRTY MINUTES. THIS REPORT IS FOR AN UNKNOWN POWER TOOL. THIS IS REPORT 4 OF 5 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
383711		INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH	HWE	SYNTHES USA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention