MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,DISTAL BICEPS, BC; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IMPL DELIVERY SYS,DISTAL BICEPS, BC
Medical Device Problem Codes	Increased Sensitivity (2535); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Burning Sensation (2146)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 5/24/2023, it was reported by a patient via email that an ar-2260bc biocomposite distal biceps repair implant delivery system was implanted during a procedure.The patient may be experiencing hypersensitivity to the implant.No further information was provided.Additional information received on 5/30/2023: the patient had a bicep repair procedure on the right shoulder and is experiencing hives around the area, itching, burning, and poking.The patient was sent to an allergist specialist; blood work is still pending.The patient has not had a revision surgery; arthrex products are still implanted.
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.
Additional Manufacturer Narrative
The complaint is not confirmed.Per event description: "ar-2260bc biocomposite distal biceps repair implant delivery system was implanted during a procedure.The patient may be experiencing hypersensitivity to the implant." it is concluded that the patience was experiencing discomfort/hypersensitivity to the implant.The most likely cause for the reported failure is due to a patient-specific event.Per dfu-0314-1 at revision 0.C.Contraindications.3.Foreign-body sensitivity.Where material sensitivity is suspected, appropriate tests should be made, and sensitivity ruled out prior to implantation.D.Adverse effects.2.Foreign body reactions.3.Allergies and other reactions to device materials.4.Allergic-like reactions to pla materials (plla, pldla) have been reported.These reactions have sometimes necessitated the removal of the implant.Patient sensitivity to device materials must be considered prior to implantation.5.Silicone sensitivity, though very rare, has been reported.

• Brand Name: IMPL DELIVERY SYS,DISTAL BICEPS, BC
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 17152457
• Report Number: 1220246-2023-06922
• Device Sequence Number: 12186524
• Product Code: MAI
• UDI-Device Identifier: 00888867204645
• UDI-Public: 00888867204645
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K062747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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: 09/30/2022
• Device Model Number: IMPL DELIVERY SYS,DISTAL BICEPS, BC
• Device Catalogue Number: AR-2260BC
• Device Lot Number: 11818871
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown