MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPS-ITE CRKSCRW 5.5X14.7MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMPS-ITE CRKSCRW 5.5X14.7MM
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	12/29/2020
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.
Event or Problem Description
It was reported that a patient is having some allergic type symptoms and the surgeon believes it could be related to the bio-composite material of the patient's ar-1927bcf-3 and ar-2324bcc implants.Additional information obtained 1/11/21: the case was performed over 4 years ago.It was a supraspinatus repair.Sales representative has requested additional information from the surgeon who has yet to provide a response.

• Brand Name: BIO-COMPS-ITE CRKSCRW 5.5X14.7MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11186418
• Report Number: 1220246-2021-02479
• Device Sequence Number: 16326049
• Product Code: MAI
• UDI-Device Identifier: 00888867023369
• UDI-Public: 00888867023369
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2021

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: BIO-COMPS-ITE CRKSCRW 5.5X14.7MM
• Device Catalogue Number: AR-1927BCF-3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other