MAUDE Adverse Event Report: ARTHREX, INC. TENO SCRW,BIO-COMP; SCREW, FIXATION, BONE

Model Number AR-1530BC

Device Problems Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 11/09/2021

Event Type  Injury  

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.

Event Description

It was reported that during a plantar plate repair with cpr kit and an edb transfer using the mini biotenodesis multiple issues occurred with several devices.The surgeon reported that cpr went well until fixing the weil¿s osteotomy.Initially the surgeon struggled to snap off the twist off screw.The first one he only partially bent it on hen engaged the drill so it span around.He then tried another screw in a different position and it seemed fine.After the first screw for the edb transfer went in find the second tenodesis screw did not.The surgeon kept pushing and twisting but no engagement beyond a certain point.Screwdriver snapped leaving a piece of wire embedded in the screw.He then tried to twist further but screw came out.He tried another one but after inserting the screwdriver handle would not disengage from the screw.The wire holding the tendon for transfer snapped and therefore this part of the procedure did not work.The surgeon tried another twist off but it did not snap.It was further reported that due to these failures the bone was damaged.This meant there wasn¿t space or quality of bone left to finish the procedure.17-nov-2021 update: further information were provided that the surgery started with the weil¿s osteotomy, then the plantar plate repair.This all went smoothly.Then the surgeon isolated the edb tendon and drilled 2 x 2.5mm holes using the mini biotenodesis disposables set ar-1530ds, he then inserted a 3x8mm biotenodesis screw (ar-1530bc) in the proximal hole which went fine.The surgeon then tried to insert the second screw in using an identical product but the screw would not engage with the tendon and hole.When he had inserted it and tried to disengage the screw driver, the screw came out with the screw driver.He tried this a couple more times until it finally worked.However it was slightly prominent, he went to tighten it and the screw came out again.He had by this point trimmed the tape and suture on the end of the tendon so was unable to tension again to finish that aspect of the procedure.The surgeon reported that the procedure could not be finished as planned and it is unclear if the plantar plate repair is enough to alleviate the patient pain.The following devices were used during the procedure: ar-1530ds-1 lot: 12161979.Ar-1530bc lot: 12649748.Ar-1530bc lot: 11793696.Ar-8930-12s lot: 10574389.Ar-8690ds lot: 10300450.Ar-8930-11s lot: 10350805.Ar-8941ks lot:11790344 x3.Ar-7232-03-01 lot: 19272.

• Brand Name: TENO SCRW,BIO-COMP
• Type of Device: 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: 12896853
• MDR Text Key: 286499128
• Report Number: 1220246-2021-04018
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867018600
• UDI-Public: 00888867018600
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AR-1530BC
• Device Catalogue Number: AR-1530BC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other