MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE; POLYETHYLENE SYNTHETIC SUTURE

Model Number	FIBERTAPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
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 9/11/2023, it was reported by an arthrex subsidiary employee via email that an ar-7237-7 fibertape broke when tensioning it.The case was completed using a product from another manufacturer.This was discovered during a procedure on (b)(6) 2023.Additional information requested.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b5 and h6.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
Additional information received from customer: the event occurred during a rotator cuff repair surgery.There was no case delay, and all the fragments were retrieved from inside the patient.
Additional Manufacturer Narrative
The complaint allegation is not confirmed.One unpackaged ar-7237-7 serial/batch number (b)(6) was received for investigation.Upon evaluation, the transition suture was noted to be frayed.Both ends of the tip were stiffened, an indication that the suture tails were intact.The evaluation included measuring the overall length using drawing specifications.C0672 at revision 35 (overall length 30.0 ±.5).The result, 29.5in the returned device, is within tolerance¿no problem found.No functional test is applicable for this device.User error is the most likely cause(s) of the reported failure.Refer to investigation photos.

• Brand Name: FIBERTAPE
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 17898862
• Report Number: 1220246-2023-08116
• Device Sequence Number: 14297752
• Product Code: GAT
• UDI-Device Identifier: 00888867041769
• UDI-Public: 00888867041769
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2024

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: FIBERTAPE
• Device Catalogue Number: AR-7237-7
• Device Lot Number: 100099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 09/26/2023; 07/05/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 10/16/2023; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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
• Patient Sex: Unknown