MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,DISTAL BICEPS REPR; BONE FIXATION PLATE

Model Number	IMPL DELIVERY SYS,DISTAL BICEPS REPR
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/07/2017
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 therefore the complainant's event could not be verified.The root cause of the event could not be determined from the information available and without device evaluation.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Patient sensitivity to materials must be considered prior to implantation.
Event or Problem Description
An initial inquiry was received that indicated a patient has been experiencing issues since receiving an arthrex implant.On (b)(6) 2019 the surgeon confirmed that he was not reporting an adverse event.He stated that he has a very difficult patient who had a distal bicep repair which has healed.The patient has pain and crazy symptoms (type of symptoms were requested but surgeon did not elaborate).There is nothing on his exam or mri to indicate there is a problem with the implant.A second opinion physician had posed the question of peek allergy/sensitivity.The surgeon had reached out to arthrex in an attempt to obtain a flat sample to put on the patient¿s skin for testing.At this time specific part numbers had not been provided.Arthrex requested additional information.On (b)(6) 2019 the surgeon responded providing the specific part number, ar-2260 (lot 10022755) distal bicep kit with peek biotenodesis screw.Date of patient surgery was (b)(6) 2017.Surgeon states patient has always had pain with no discernible change from pre-op to post-op.Patient has undergone extensive diagnostic evaluation including mri.Patient has numerous allergies so medical treatment is difficult.Patient has undergone therapy.No infection present.Patient has had no positive test results.Mri is stable.Patient does have lateral antebrachial nerve hypoaesthesia.No further surgery is scheduled.On (b)(6) 2019 surgeon was provided with the material composition of the patient¿s implant (screw-peek optima, biceps button-titanium alloy, suture-polyester and ultra high molecular weight polyethylene.Arthrex does not have and is unable to provide the surgeon with a flat sample for patch testing use.Follow up information received 8/31/2023: it was reported in the medical records received that after patch testing was performed on the patient in (b)(6) 2019 it was determined he was allergic to the peek anchor.A removal surgery was performed on (b)(6), 2019.No further details were provided on the removal.
Additional Manufacturer Narrative
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 for the reported failure can be attributed to a patient-specific event.

• Brand Name: IMPL DELIVERY SYS,DISTAL BICEPS REPR
• Common Device Name: BONE FIXATION PLATE
• 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: 18040589
• Report Number: 1220246-2023-08474
• Device Sequence Number: 7344665
• Product Code: HRS
• UDI-Device Identifier: 00888867026476
• UDI-Public: 00888867026476
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K062747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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 Expiration Date: 12/31/2020
• Device Model Number: IMPL DELIVERY SYS,DISTAL BICEPS REPR
• Device Catalogue Number: AR-2260
• Device Lot Number: 10022755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2016
• 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