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

Model Number	CERCLAGE TENSIONER RATCHETING HANDLE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
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 9/22/2023, it was reported by a sales representative via sems-06038847 that an ar-7800 fibertape cerclage tensioner and an ar-7801 cerclage tensioner ratcheting handle had an issue, the tensioner was cutting the tape when tensioning.This occurred during use in an unspecified procedure on (b)(6) 2023 with no patient harm.Additional information has been requested.On 9/26/2023, the sales representative provided the following information via phone: this occurred during a sternal closure procedure.When the tensioner was cutting the tape, all fragments of the tape were removed from the patient.A disposable tensioner was used to complete the procedure successfully.There was no adverse effect to the patient reported and no case delay.
Additional Manufacturer Narrative
Complaint is not confirmed.Upon functional testing, the ratcheting mechanism worked as required, and no issues were found with the device.No problem found.Upon visual evaluation, some rust spots on the metal part of the device were noticed.

• Brand Name: CERCLAGE TENSIONER RATCHETING HANDLE
• 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: 17975456
• Report Number: 1220246-2023-08276
• Device Sequence Number: 3568633
• Product Code: LXH
• UDI-Device Identifier: 00858325005176
• UDI-Public: 00858325005176
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/13/2024

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: CERCLAGE TENSIONER RATCHETING HANDLE
• Device Catalogue Number: AR-7801
• Device Lot Number: 143864
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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