MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER¿ HAMMERTOE FIXATION IMPLANT; FIXATION, PIN, SMOOTH

Model Number 2.9X19 MM STRAIGHT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

A product investigation was performed for this device.The actual device could not be examined as it was not removed.Implants are supplied sterile from a validated sterilization process.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use.There are no indications of a product or process issue affecting implant safety or effectiveness.There have been no suspected infections from this batch.In addition, immediate post-operative imaging showed that direct bone to bone contact was not achieved and a gap remained at the osteotomy site.Such a gap has the potential to lead to instability following the procedure, which could cause swelling and fluid accumulation.Instability was observed in images taken on six and eight-week post-op.At the time of this report there is no evidence that there is an infection at the implant site.There were no findings that indicate that the reported device was the root cause or had a direct connection with the patient's suspected infection.The root cause of the swelling is undetermined.However, because the company cannot rule out the possible contribution of the implant to the event, out of an abundance of caution and in the interest of compliance, this event is being reported.Company continues to monitor these events as part of our post market activities.(additional reports related to this event are: # 3014323288-2019-00001, # 3014323288-2019-00002).

Event Description

Surgeon alerted the company rep that a patient is experiencing swelling and pain 6 weeks following implantation of ossiofiber hammertoe fixation implant, 2.9x19 (medium, straight) in a proximal interphalangeal joint of 2nd toe.Infection was suspected at the operated site of 2nd toe.No samples were sent for diagnostic testing.Patient was prescribed with antibiotics.During implantation, hammertoe instrumentation, size medium (t.A.G medical products corporation ltd.) were utilized as disposable instruments for the preparation of the implantation site.During the same surgery, screws by another manufacturer were implanted in the 1st ray.A soft tissue release procedure was performed on the 5th toe.Implant removal surgery from the 2nd toe was scheduled for the seventh-week post-op, but the patient did not present.Additional imaging was performed on the patient eight weeks post-op.Patient was re-scheduled for an mri and a removal operation the following week.The patient did not present again.Patient has not responded to queries and doctor and facility have not had contact with patient after or aware of any additional medical treatment or consultation received elsewhere.

Event Description

Ossio was notified that, according to doctor, issue resolved itself by (b)(6) 2019.

• Brand Name: OSSIOFIBER¿ HAMMERTOE FIXATION IMPLANT
• Type of Device: FIXATION, PIN, SMOOTH
• Manufacturer (Section D): OSSIO LTD.; 8 hatochen st.; caesarea, 30798 6; IS 307986
• MDR Report Key: 8777461
• MDR Text Key: 150607393
• Report Number: 3014554088-2019-00001
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• PMA/PMN Number: K181180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2019
• Device Model Number: 2.9X19 MM STRAIGHT
• Device Catalogue Number: OF10129190
• Device Lot Number: OF00048
• Was Device Available for Evaluation?: No
• Device Age: 3 WK
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: 06/13/2019
• Supplement Dates FDA Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1ST TOE HAD SCREWS IMPLANTED IN SAME OPERATION; 5TH TOE HAD A SOFT TISSUE RELEASE PROCEDURE; HAMMERTOE INSTRUMENTATION (T.A.G. MEDICAL LTD.); IMPLANT DIPPED IN GENTAMYCIN PRIOR TO IMPLANTATION; IV ANCEF, VANOMYCIN BEFORE PRIMARY SURGERY; SCREWS WERE DIPPED IN SAME SOLUTION BEFORE IMPLANT; 1ST TOE HAD SCREWS IMPLANTED IN SAME OPERATION; 5TH TOE HAD A SOFT TISSUE RELEASE PROCEDURE; HAMMERTOE INSTRUMENTATION (T.A.G. MEDICAL LTD.); IMPLANT DIPPED IN GENTAMYCIN PRIOR TO IMPLANTATION; IV ANCEF, VANOMYCIN BEFORE PRIMARY SURGERY; SCREWS WERE DIPPED IN SAME SOLUTION BEFORE IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 86