MAUDE Adverse Event Report: T.A.G. MEDICAL PRODUCTS CORPORATION LTD. HAMMERTOE INSTRUMENT KIT, SIZE MEDIUM; BIT, DRILL

Catalog Number THN00001

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

Manufacture shared that: "dhr review shows no issue during sterilization and product was released according to routine procedure." additional reports related to this event are: # 3014323288-2019-00001, # 3014554088-2019-00001.

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 aug 19, 2019.

• Brand Name: HAMMERTOE INSTRUMENT KIT, SIZE MEDIUM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): T.A.G. MEDICAL PRODUCTS CORPORATION LTD.; kibbutz gaaton; gaaton, 25130 00; IS 2513000
• MDR Report Key: 8777476
• MDR Text Key: 150605389
• Report Number: 3014323288-2019-00002
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10818674021460
• UDI-Public: (01)10818674021460(17)230130(10)18J01
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 07/10/2019,10/24/2019

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: 01/30/2023
• Device Catalogue Number: THN00001
• Device Lot Number: 18J01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2019
• Distributor Facility Aware Date: 06/13/2019
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: Not provided
• 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; IMPLANT DIPPED IN GENTAMYCIN PRIOR TO IMPLANTATION; IV ANCEF, VANOMYCIN BEFORE PRIMARY SURGERY; OSSIOFIBER HAMMERTOE FIXATION IMPLANT 2.9X19; SCREWS WERE DIPPED IN SAME SOLUTION BEFORE IMPLANT; 1ST TOE HAD SCREWS IMPLANTED IN SAME OPERATION; 5TH TOE HAD A SOFT TISSUE RELEASE PROCEDURE; IMPLANT DIPPED IN GENTAMYCIN PRIOR TO IMPLANTATION; IV ANCEF, VANOMYCIN BEFORE PRIMARY SURGERY; OSSIOFIBER HAMMERTOE FIXATION IMPLANT 2.9X19; SCREWS WERE DIPPED IN SAME SOLUTION BEFORE IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 86