FDA Adverse Event Injury Summary report: N

HELIX BLADE 85MM

MDR report key: 3884277 · Received June 19, 2014

Report

Report Number: 2520274-2014-12021
Event Type: Injury
Date Received: June 19, 2014
Date of Event: May 26, 2014
Report Date: May 26, 2014
Manufacturer: SYNTHES (USA)
Product Code: JDO
PMA / PMN Number: PK981757
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MT, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

IT WAS REPORTED DURING AN OPEN REDUCTION INTERNAL FIXATION OF A HIP FRACTURE ON (B)(6) 2014 USING THE DHS DCS DYNAMIC HIP AND CONDYLAR SCREW SYSTEM, THE SURGEON WAS IMPACTING THE HELICAL BLADE AND THE BLADE PUSHED THROUGH THE FEMORAL HEAD. THE SURGEON USED A REMOVAL TOOL TO BACK OUT THE BLADE AND PUT A NEW PLATE BACK INTO PLACE USING THE SAME HELICAL BLADE. A 10 MINUTE SURGICAL DELAY WAS REPORTED, THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS NOTED THAT THE PHYSICIAN DID USE THE PLATE ALIGNMENT KEY PRIOR TO INSERTION SO ALL OF THE MEASUREMENTS WERE CORRECT. IT IS ALSO CONFIRMED THAT THERE ARE NO ALLEGATIONS OR COMPLAINTS AGAINST THE PLATES, DEVICES ARE NOT AVAILABLE FOR RETURN. THIS IS REPORT 2 OF 2 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
360214	HELIX BLADE 85MM	APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR	JDO	SYNTHES (USA)

Patients

Seq	Age	Sex	Outcome	Treatment
1	87 YR		Required Intervention