MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO-CORKSCREW FT; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTURE ANCHOR, BIO-CORKSCREW FT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Nausea (1970); Pain (1994); Dizziness (2194)
Date of Event	01/14/2022
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
It was reported by a patient that after a supraspinatus tendon surgery, he has developed an allergy or intolerance.Further information was requested.Update on 09-jan-2026 - further information was received: on (b)(6) 2022, the patient underwent surgery to repair a supraspinatus tendon rupture in the right shoulder.Postoperatively, the patient reported severe pain in the operated area, which was treated using a pain catheter.Since on (b)(6) 2022, the patient developed nausea and dizziness when extending the right arm backwards while simultaneously looking upward.Additional symptoms include pain in the upper body, tingling in the arms, and rapid physical exhaustion.The symptoms have become increasingly severe and the pain in the right arm, upper body, and head has become chronic.Multiple examinations in internal medicine, cardiology, pulmonology, and neurology did not identify a cause.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is not confirmed.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 of the reported failure is a patient-specific event.Refer to dfu-0087-eo warnings 8.Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.14.Bioabsorbable only: patient sensitivity to the device materials should be considered prior to implantation.See adverse effects.And adverse effects 3.Bioabsorbable only: allergic-type reactions to pla (poly lactic acid) materials (plla (poly-l-lactic acid), pldla (poly-l-d-lactic acid)) have been reported.These reactions have sometimes necessitated the removal of the implant.Patient sensitivity to device materials must be considered prior to implantation.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.
Event or Problem Description
Update on 26-mar-2026 - further information was received: upon reviewing the surgical images from (b)(6) 2022, the surgeon has not noticed any abnormalities so far.It is not possible to conclusively determine whether the symptoms described by the patient were caused by a medical device.In addition, the surgeon confirmed that no broken pieces or metal debris from the burr remained inside the patient.

• Brand Name: SUTURE ANCHOR, BIO-CORKSCREW FT
• 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: jared engle ; 8009337001
• MDR Report Key: 24144167
• Report Number: 1220246-2026-00273
• Device Sequence Number: 21203837
• Product Code: MAI
• UDI-Device Identifier: 00888867023352
• UDI-Public: (01)00888867023352(11)201214(17)241130(10)12300702
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2026

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 Expiration Date: 11/30/2024
• Device Model Number: SUTURE ANCHOR, BIO-CORKSCREW FT
• Device Catalogue Number: AR-1927BCF
• Device Lot Number: 12300702
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/16/2026; 03/26/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/16/2026; 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2020
• 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: Male