MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE WITH FIBERTAG; PIN, FIXATION, SMOOTH

Model Number ACL TIGHTROPE WITH FIBERTAG

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2022

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 anterior cruciate ligament (quads graft) the needle was broken during hemming.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.The device is involved in an unspecified injury to a 40-year-old male patient.

Manufacturer Narrative

Complaint is confirmed.One unpackaged (b)(6) acl fibertag serial/batch number (b)(6) was received for investigation.Visual evaluation found the needle was no longer attached to the device.More in-depth visual evaluation did not find issues with the device.The cause remains undetermined.

Event Description

It was reported that during an anterior cruciate ligament (quads graft) the needle was broken during hemming.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 nen 30-dec-2022: the incident occurred during the operation at the beginning of stitching.The device was not used in the patient.Update nen 12-jan-2023: further information revealed that the device broke before insertion and no broken piece remained in the patient.There was no harm for patient, operator or third party.

Manufacturer Narrative

Additional info: b5.

• Brand Name: ACL TIGHTROPE WITH FIBERTAG
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 16120623
• MDR Text Key: 308711693
• Report Number: 1220246-2023-06065
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867308459
• UDI-Public: 00888867308459
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K112990
• 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,Followup
• Report Date: 05/02/2023

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
• Device Operator: Health Professional
• Device Model Number: ACL TIGHTROPE WITH FIBERTAG
• Device Catalogue Number: AR-1588RTT
• Device Lot Number: 14935266
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 12/23/2022; 12/23/2022
• Supplement Dates FDA Received: 03/07/2023; 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1