FDA Adverse Event Injury Summary report: N

ARROW-LOK DIGITAL FUSION SYSTEM

MDR report key: 3142461 · Received March 28, 2013

Report

Report Number
3008817603-2013-00001
Event Type
Injury
Date Received
March 28, 2013
Date of Event
January 9, 2013
Report Date
March 25, 2013
Manufacturer
ARROWHEAD MEDICAL DEVICE TECHNOLOGIES
Product Code
HTY
PMA / PMN Number
K112675
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THE PT (B)(6), AGE (B)(6), HAD NUMEROUS SURGICAL PROCEDURES ON (B)(6) 2013 BY DR (B)(6). ALL OF THESE PROCEDURES WERE HAMMERTOE CORRECTION ON THE SECOND, THIRD, AND FOURTH DIGITS OF THE RIGHT FOOT. THE PT HAD SIGNIFICANT POSTOPERATIVE SWELLING. THE PT HAS CIRCULATORY ISSUES RELATED TO LUPUS AND RHEUMATOID ARTHRITIS. FOLLOWING THE SURGICAL PROCEDURE HER CIRCULATION WAS COMPROMISED. ALONG WITH THE COMPROMISED CIRCULATION IN THE SWELLING, THE FOURTH TOE BECAME A CONCERN. RADIOGRAPHICALLY IT WAS OBVIOUS THAT THE HAMMERTOE IMPLANT WAS NOT SEATED DEEPLY ENOUGH INTO THE INTERMEDIATE PHALANX. THE INTERMEDIATE PHALANX HAD SLIPPED OFF OF THE DISTAL ASPECT OF THE IMPLANT. THERE WAS NO FAILURE WITH THE IMPLANT ITSELF. WITH THE FACT THAT IT WAS NOT SEATED DEEPLY ENOUGH INTO THE INTERMEDIATE PHALANX AND THE SIGNIFICANT EDEMA, SHE HAD A DISLOCATION. WITH THE SIGNIFICANT PROBLEMS THAT SHE WAS ALREADY HAVING DR (B)(6) DID NOT FEEL THAT IT WAS SAFE TO LEAVE THE IMPLANT. IT COULD CAUSE MORE SOFT TISSUE EDEMA OR EVEN PIERCE THE SKIN. DR (B)(6) MADE THE DECISION ON (B)(6) 2013 TO REMOVE THE IMPLANT. THE EXPLANT WAS PERFORMED IN THE OFFICE UTILIZING STERILE TECHNIQUE. THE REMOVAL WAS UNEVENTFUL. THE PT WENT ON TO HEAL WITH NO LONG-TERM COMPLICATIONS. DR (B)(6) COMMUNICATED THAT THIS WAS NOT AN IMPLANT FAILURE AND THAT HE REALIZES THAT THE IMPLANT NEEDS TO BE ADVANCED MORE DEEPLY INTO THE MIDDLE PHALANX THAN IT WAS IN THIS PT. DR (B)(6) COMMUNICATED THAT HE PROBABLY COULD HAVE IMPLANTED THE DEICE DEEPER TO 8, 9 OR EVEN 10 MM. TWO OF THE THREE IMPLANTS PERFORMED ON THE PT REMAINED IMPLANTED WITHOUT EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
129572 ARROW-LOK DIGITAL FUSION SYSTEM DIGITAL FIXATION DEVICE HTY ARROWHEAD MEDICAL DEVICE TECHNOLOGIES 61-253519 V-3018

Patients

Seq Age Sex Outcome Treatment
1 57 YR Required Intervention NONE KNOWN