MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS, MPFL, TIGHTROPE; SCREW, FIXATION, BONE

Model Number	IMPL SYS, MPFL, TIGHTROPE
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Review of this complaint confirmed the event summary code selection.A product history review was performed as required.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The probable cause of the event could not be determined from the information available and without device evaluation.As no further investigation was able to be performed no change in harm was identified.Complaint trending for this event will be performed per wi-000100100.
Event or Problem Description
On 08/04/2022, it was reported by a sales representative via email that a ar-1360tr-bc tightrope did not have any free tensioning ends and was tangled within itself whenever the scrub tech unfolded the white packaging that the tightrope was contained in.This was discovered during an unknown case on (b)(6) 2022, with no patient effect reported.No additional information provided.Additional information requested.Additional information provided on 08/05/2022, it was reported that this occurred during a mpfl case.

• Brand Name: IMPL SYS, MPFL, TIGHTROPE
• Common Device Name: 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: jared engle ; 8009337001
• MDR Report Key: 19457656
• Report Number: 1220246-2024-04815
• Device Sequence Number: 12465610
• Product Code: HWC
• UDI-Device Identifier: 00888867354074
• UDI-Public: 00888867354074
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K201749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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 Expiration Date: 01/31/2026
• Device Model Number: IMPL SYS, MPFL, TIGHTROPE
• Device Catalogue Number: AR-1360TR-BC
• Device Lot Number: 14925371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown