MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS, 14 MM BUTTON; SMOOTH FIXATION PIN

Model Number	TIGHTROPE ABS, 14 MM BUTTON
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
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
On 10/17/2023, it was reported by a distributor via sems that an ar-1588tb-1 round tightrope abs button, 14mm, broke into two pieces when the surgeon flexed the knee after performing the final tightening.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-1588tb-1 round tightrope abs button was received for evaluation.Functional testing could not be performed due to the damage to the device.Visual inspection noted that the device was broken into two pieces.The width of both halves were measured using a blade micrometer and it was found that the dimensions were.057 and.057 which are in tolerance of the specified.059 ±.005.The dimensions for the width are specified in drawing c6342 revision 1.The most likely cause for the reported failure can be attributed to user error of the device due to over-tightening the button.

• Brand Name: TIGHTROPE ABS, 14 MM BUTTON
• Common Device Name: SMOOTH FIXATION PIN
• 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: emily shafer ; 8009337001
• MDR Report Key: 18101595
• Report Number: 1220246-2023-08632
• Device Sequence Number: 18071831
• Product Code: HTY
• UDI-Device Identifier: 00888867019638
• UDI-Public: 00888867019638
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K110123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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 Model Number: TIGHTROPE ABS, 14 MM BUTTON
• Device Catalogue Number: AR-1588TB-1
• Device Lot Number: 15096268
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown