MAUDE Adverse Event Report: ARTHREX, INC. 4.5 BIOCOMPOSITE FT WITH TIGERTAIL; BIO SOFT TISSUE FIXATN FASTNR

Model Number	4.5 BIOCOMPOSITE FT WITH TIGERTAIL
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a rotator cuff surgery, issues with two anchors occurred.During the insertion of the first anchor, the corksrew frayed during the tenodesis.The second anchor could not be fixated and the surgeon was able to pull the anchor out without cutting the sutures as the sutures were stuck inside.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.
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
16-oct-2023 update dw.Further information were provided that the initially provided part number ar-1927bcft-45-1 was incorrect.The issue was related to an ar-1927bcf-45-1 and that the suture of the first anchor frayed and everything was retrieved out of the patient.The second anchor could be fixated however the suture on the top of the corkscrew became stuck and the surgeon had to cut it through to finish the surgery successfully.
Additional Manufacturer Narrative
Additional info: b5, h6 updated correction: h1 to n/a.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon receiving additional information from the field that clarified the event and evaluation of the returned devices, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.

• Brand Name: 4.5 BIOCOMPOSITE FT WITH TIGERTAIL
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 17939275
• Report Number: 1220246-2023-08208
• Device Sequence Number: 6472773
• Product Code: MAI
• UDI-Device Identifier: 00888867096851
• UDI-Public: 00888867096851
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082810
• 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
• Report Date (Section B): 02/20/2024

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: 4.5 BIOCOMPOSITE FT WITH TIGERTAIL
• Device Catalogue Number: AR-1927BCFT-45-1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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