MAUDE Adverse Event Report: ARTHREX, INC. BIO-COM-TENO SCW W/DIS DRV 4.75X15MM,VE1; SCREW, FIXATION, BONE

Model Number	BIO-COM-TENO SCW W/DIS DRV 4.75X15MM,VE1
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament ankle surgery when screwing the screw to maintain the ligament the suture was cut three times.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update 17-jan-2023.This event occurred during the insertion of the biotenodesis screw 4.75 into the talar tunnel with the tendon graft held at the end of the device by the preassembled retaining wire.While the surgeon inserted the screw, the fiber wire holding the tendon graft at the end of the implant broke, causing the tendon graft to protrude out of the tunnel.Due to this failure the screw had to be removed in order to correctly reinsert the graft at the bottom of the tunnel with a new implanting device.The wire preassembled on the bio-tenodial screw was found to be broken on these 3 placements, making it impossible of introducing it at the bottom of the tunnel.As the screw itself was not damaged, it was not possible to add a grab wire to the device to hold the ligament graft and retry insertion of the graft into the talar tunnel.The surgeon assumed that the problem was caused by the breakage of the premounted fibrous wire of the screw.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged ar-1547cds-1 serial/batch number (b)(6) was received for investigation.Functional test of the only received parts, the driver outer sleeve and the tb inner member molded swivelock found that the devices thread smoothly.Visual evaluation of the attached picture note that the device on the bag still has something that looks like the bio screw but no sutures are attached to the shaft.However, the updated case explained," the fiberwire holding the ligamentous graft at the end of the implant broke 3 times, causing the ligamentous graft to protrude from the tunnel when the screw was inserted, and the screw had to be removed in order to correctly reinsert the graft at the bottom of the tunnel with a new implanting device." the most likely cause(s) of this type of event include excessive bending force applied to the device during use.

• Brand Name: BIO-COM-TENO SCW W/DIS DRV 4.75X15MM,VE1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16303053
• Report Number: 1220246-2023-06225
• Device Sequence Number: 6166138
• Product Code: HWC
• UDI-Device Identifier: 00888867233959
• UDI-Public: 00888867233959
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: BIO-COM-TENO SCW W/DIS DRV 4.75X15MM,VE1
• Device Catalogue Number: AR-1547CDS-1
• Device Lot Number: 15003980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown