MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS BUTTON ROUND 20MM CONCAVE; PIN, FIXATION, SMOOTH

Model Number	TIGHTROPE ABS BUTTON ROUND 20MM CONCAVE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery when the surgeon stretched the implant ar-1588rtt during the surgery as a technique, without applying additional force the implant ar-1588rtt broke and the surgery with this implant could no longer be continued.The broken pieces were retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device from a different manufacturer.It was not necessary to switch the surgical technique or do a second surgery.Because the implant was in contact with the patient, it was discarded during surgery.

• Brand Name: TIGHTROPE ABS BUTTON ROUND 20MM CONCAVE
• Common Device Name: 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: 13087760
• Report Number: 1220246-2021-04186
• Device Sequence Number: 17489651
• Product Code: HTY
• UDI-Device Identifier: 00888867240582
• UDI-Public: 00888867240582
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K110123
• 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
• Report Date (Section B): 12/27/2021

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: 05/31/2026
• Device Model Number: TIGHTROPE ABS BUTTON ROUND 20MM CONCAVE
• Device Catalogue Number: AR-1588TB-5
• Device Lot Number: 13474721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/27/2021
• Date Device Manufactured: 06/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown