FDA Adverse Event Injury Summary report: N

SCREW

MDR report key: 2781832 · Received October 11, 2012

Report

Report Number: 2520274-2012-02233
Event Type: Injury
Date Received: October 11, 2012
Date of Event: September 13, 2012
Report Date: September 13, 2012
Manufacturer: SYNTHES USA
Product Code: HWC
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

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.

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

Description of Event or Problem · 1

PATIENT SUSTAINED AN ANKLE INJURY IN (B)(6) 2005. ON (B)(6) 2005, THE PATIENT WAS FIXED WITH AN EXTERNAL FIXATION. ON (B)(6) 2005, THE PATIENT WAS FIXED WITH AN UNKNOWN INTERNAL FIXATION. THE PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2008 FOR AN ANKLE FUSION AND WAS IMPLANTED WITH A SUBJECT PLATE, SCREWS AND A BONE GRAFT. ON (B)(6) 2012, THE PATIENT WAS AGAIN TAKEN TO THE OR FOR REMOVAL OF THE PLATE, 6 SCREWS (THREE OF WHICH WERE BROKEN) DUE TO NON-FUSION. THE PATIENT WAS REVISED WITH NEW PLATE AND BONE GRAFT. IT WAS REPORTED THAT THE REMOVED IMPLANTS WERE DISCARDED OF BY THE ACCOUNT AFTER THE PROCEDURE AND WILL NOT BE RETURNED FOR INVESTIGATION. THIS IS 4 OF 7 REPORTS FOR THE SAME EVENT.

Description of Event or Problem · 1

SURGEON REPORTS PATIENT SUFFERED RIGHT ANKLE PILON FRACTURE (CLOSED) SUSTAINED IN 2005 AT MAYO CLINIC. PATIENT DEVELOPED POST TRAUMATIC DEGENERATIVE JOINT DISEASE. ORIGINAL FUSION FAILED DUE TO BROKEN HARDWARE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SCREW	SCREW	HWC	SYNTHES USA

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Required Intervention	PLATE, SCREWS