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

Model Number	SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
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 2/2/2024, it was reported by a sales representative via email that an ar-1926bc biocomposite pushlock was implanted in a patient.Post-operative, the patient is experiencing an allergic reaction.It has not been confirmed if the allergy is due to the arthrex implant.No further information has been provided.Additional information requested.
Event or Problem Description
Additional information received on 2/2/2024: this was discovered after an arthroscopic rcr, subacromial decompression, and labrum limited debridement procedure on (b)(6) 2023.The patient experienced rashes, hives, redness, and itchiness.The reaction was not localized at the surgical site; it began under the arm, later spreading to the chest and opposite extremities.The reaction was identified approximately one-week post-operation.The patient went to urgent care and was given clotrimazole, which slightly worsened the reaction.The patient tried hydrocortisone ointment and took prednisone and zyrtec.The reaction continued, and the patient made several trips to urgent care.The patient received fifty milligrams of benadryl injections at least three times during urgent care visits.The patient was also treated with xolair during one of the urgent care visits.The patient consulted with a dermatologist and was prescribed allegra with zyrtec.The patient continues to take prednisone and hydroxyzine pamoate.The patient will be consulting an allergist.All the implants remain in the patient.
Additional Manufacturer Narrative
Additional information: b.5 event updated, g.3 follow-up information received.
Additional Manufacturer Narrative
Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that a patient-specific event is the most likely cause of the reported failure.Directions for use (dfu) dfu-0087-eo corkscrew®, pushlock®, and swivelock® suture anchors.Section d.Adverse effects.1.Infections, both deep and superficial.2.Foreign body reactions.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.The complaint allegation was not confirmed, the device was not received for evaluation, and no evidence of the failure was received.

• Brand Name: SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK
• 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: 18686763
• Report Number: 1220246-2024-00911
• Device Sequence Number: 6509340
• Product Code: MAI
• UDI-Device Identifier: 00888867023239
• UDI-Public: 00888867023239
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101679
• 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,Followup
• Report Date (Section B): 05/22/2025

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: SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK
• Device Catalogue Number: AR-1926BC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 02/02/2024; 05/08/2025
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 02/27/2024; 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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