MAUDE Adverse Event Report: ARTHREX, INC. FIBERSTITCH IMPLANT, STRAIGHT RC; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERSTITCH IMPLANT, STRAIGHT RC
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	07/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/15/2024, it was reported by a patient via phone that she was experiencing pain and inflammation post-operatively and inquired about the material composition of several known and unknown arthrex products.During an initial rotator cuff repair procedure on (b)(6) 2023, qty.2 of an ar-2324bcm suture anchor, bio-composite swivelock sp, an ar-3633sp fibertak sp suture anchor, and an ar-3670 fibertak biceps implant system were implanted.After 6 weeks post-op, the patient experienced increasing pain and inflammation, but the initial surgeon did not want to perform revision surgery and stated that nothing was wrong.The patient then went to another surgeon who performed revision surgery on the right shoulder on (b)(6) 2024.It was found that the sutures to one of the anchors were loose; nothing had broken inside the patient.The surgeon cut the loose sutures and removed them, but the anchor and all other devices from the initial surgery remained inside the patient.During the additional procedure, additional unknown arthrex suture anchors, swivelock anchors, and a graft were implanted using the arthrex cuffmend system.After the additional surgery, the patient experienced pain and inflammation after 10 weeks post-op.The patient saw an allergist, and after testing, it was confirmed that the patient was allergic to cobalt, gold sodium thiosulfate (gst), and p-tert-butylphenol formaldehyde resin.The allergist had stated that cobalt might be used in orthopedic implants, and the patient, therefore, requested the material composition of the known implants and stated that she would provide the additional product part and lot numbers in writing to product surveillance for an additional material composition request.Additional information has been requested.On (b)(6) 2024, the patient provided the following additional information via email: qty.2 of an ar-2324bcm suture anchor, bio-composite swivelock sp, and qty.4 of an ar-19032s fiberstitch rc implant 1.5, straight were implanted during the second surgery.The graft implanted in her shoulder during the second procedure was not an arthrex product.The inflammation was localized to her shoulder after each surgery, and she did not experience any other symptoms she was aware of.Additional information has been requested.On (b)(6) 2024, the patient provided the following information via email: another surgery was scheduled for on (b)(6) 2024 to clean up some inflammation triggered by the sensitivity.She was not aware if anything else needed to be done at the same time.

• Brand Name: FIBERSTITCH IMPLANT, STRAIGHT RC
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 20560500
• Report Number: 1220246-2024-08317
• Device Sequence Number: 16916190
• Product Code: MBI
• UDI-Device Identifier: 10818674027417
• UDI-Public: (01)10818674027417(11)231001(17)280430(10)23N04
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K221731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FIBERSTITCH IMPLANT, STRAIGHT RC
• Device Catalogue Number: AR-19032S
• Device Lot Number: 23N04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• 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