MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE CERCLAGE TENSIONER, REUSABLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number FIBERTAPE CERCLAGE TENSIONER, REUSABLE

Device Problems Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/25/2021

Event Type  malfunction  

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 an arthro assisted latarjet surgery the patient¿s coracoid was torn through by the fibertape cerclage system and half of the glenoid was torn through due to a misunderstanding regarding the used tensioner and the scale, which led to a false adjustment of the tensioner of above 350 newtons.Two tensioners were sent out for this case which was an arthroscopic assisted latarjet cerclage.The tensioner listed (ar-7800 and ar-7801) plus the blue acl tensioner ar-1529.Ar-1529 is the tensioner that was previously always used by the arthrex employee, which max¿s out at just over 100 newtons with the unit of measure listed on there in lbf and newtons.The case went really well until tensioning where the arthrex employee didn¿t realise that the surgeon was using the black tensioner (ar- 7800 & ar-7801).This tensioner doesn¿t have the unit of measure listed on it, and the scale is in lbf.The surgeon asked how much to tension to and the arthrex employee replied that the surgeon can max the tensioner out as 100 newtons are desired, it max¿s out at that point.The surgeon then tensioned to around 80 in lbf scale, which was over 350 newtons.The patient¿s coracoid was torn through by the fibertape cerclage system and half of the glenoid was torn through.In order to remove the tapes the surgeon had to make a larger posterior incision and cut down to the glenoid to release the tapes.He then used 2 x tightrope rt¿s with 2 x dog bones over the coracoid in order to complete the procedure.The surgery was finished successfully with different devices (ar-1588rt x 2).It was not necessary to do a second surgery.No further information received.

Manufacturer Narrative

Complaint confirmed.One unpackaged ar-7800 tensioner and concomitant ar-7801 ratcheting handle were received for investigation.Visual inspection identified that the returned ar-7800 had damage to the proximal end of the c13698-01 ratchet gear, where the device mates with the ar-7801 handle, likely due to the excessive force applied to the assembly.Functional testing identified that the ar-7800 and ar-7801 were able to be assembly together, and the assembly ratcheted as intended.The cause of the event is attributed to the misuse indicated in the event description.

• Brand Name: FIBERTAPE CERCLAGE TENSIONER, REUSABLE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 13526551
• MDR Text Key: 285606491
• Report Number: 1220246-2022-04448
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867273986
• UDI-Public: 00888867273986
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FIBERTAPE CERCLAGE TENSIONER, REUSABLE
• Device Catalogue Number: AR-7800
• Device Lot Number: 051650
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2017
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other