MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLE CERCLAGE TENSIONER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DISPOSABLE CERCLAGE TENSIONER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2023
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 08/03/2023, it was reported by a sales representative via email that an ar-7820 fibertape cerclage disposable tensioner broke.This was discovered during a case, and the case was completed by using a new ar-7820.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause(s) for the reported failure is a user error applying the correct deploying technique.The surgical technique advises to "take caution to avoid over tensioning and going beyond the fourth gauge line, where the tensioner¿s spring is nearing its maximum compression.".Additionally, before retensioning, turn the handle completely counterclockwise to ensure the tensioner shaft is fully extended and in the starting position.".

• Brand Name: DISPOSABLE CERCLAGE TENSIONER
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 17662517
• Report Number: 1220246-2023-07727
• Device Sequence Number: 20600081
• Product Code: LXH
• UDI-Device Identifier: 00888867373976
• UDI-Public: 00888867373976
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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: DISPOSABLE CERCLAGE TENSIONER
• Device Catalogue Number: AR-7820
• Device Lot Number: 3039129043
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown