FDA Adverse Event Injury Summary report: N

X FUSE IMPLANT X LARGE 0 DEGREE

MDR report key: 3434012 · Received October 29, 2013

Report

Report Number: 0008031020-2013-00400
Event Type: Injury
Date Received: October 29, 2013
Date of Event: October 5, 2013
Report Date: October 5, 2013
Manufacturer: STRYKER OSTEOSYNTHESIS-SELZACH
Product Code: HTY
PMA / PMN Number: K112197
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY THE AFFECTED DEVICE WAS NOT RETURNED FOR INVESTIGATION. PROVIDED X-RAYS PERMITTED TO CONFIRM THE EVENT THAT THE IMPLANT BROKE. THE X-FUSE IMPLANT WAS USED IN THE TOE (IP). THE 2 WEEKS POST OP X-RAYS SHOW THE IMPLANT IS A BIT SMALL FOR THE PATIENT TOE AND IS NOT INSERTED AS IT SHOULD. SINCE IMMEDIATE POST OP X-RAYS WERE NOT PROVIDED, IT IS UNKNOWN OF THE IMPLANT WAS CORRECTLY IMPLANTED OR IF IT MIGRATED. THE IFU WAS REVIEWED AND READS: RECOMMENDATIONS: BASED ON CLINICAL EXPERIENCE, THE X-FUSE IS USED FOR PIP, DIP AND IP ARTHRODESES OF THE HAND OR SECONDARY TREATMENT OF PIP, DIP AND IP ARTHRODESIS OF THE FOOT AND THE SMART TOE IS USED IN PIP AND DIP ARTHRODESIS OF THE FOOT. BASED ON THE INVESTIGATION RESULTS, THIS CASE COULD BE CLASSIFIED AS USER-RELATED. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. DEVICE REMAINS IMPLANTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE POST OP X-RAYS SHOWED A SUCCESSFUL SURGERY. FOUR WEEKS POST OP X-RAYS REVEALED THAT THE MMI X-FUSE COMPONENT WAS FRACTURED IN TWO PLACES. THE PATIENT IS ASYMPTOMATIC. NO REVISION SURGERY SCHEDULED AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
554934	X FUSE IMPLANT X LARGE 0 DEGREE	IMPLANT	HTY	STRYKER OSTEOSYNTHESIS-SELZACH		F000726PAAR

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Required Intervention