MAUDE Adverse Event Report: ARTHREX, INC. H/W INTERNALBRACE LGMNT AUGMNT REPR KIT; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/31/2022
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 (b)(6) 2022, it was reported by a facility representative via email that a patient underwent a surgical procedure performed on the right hand, in (b)(6) 2021.The patient is possibly experiencing a reaction to material(s) used for the repair.The patient will be seeing an allergist on (b)(6) 2023, for sensitivity testing.No additional information was provided.Additional information requested.
Event or Problem Description
Additional event information: original procedure: (b)(6) 2022 procedure: h&w soft tissue repair.Devices used: h/w internal brace lgmnt augment repr kit ar-8978-cp lot: 13634098, disposables kit, for dx fibertak ar-8990ds lot: 10589394, dx fibertak suture anchor, st & ndls ar-8990st lot: 11843561.Additional information regarding treatment for reaction, date of reaction onset, reaction details/photos, other follow-up procedures, was requested but not provided.
Additional Manufacturer Narrative
This report is being submitted to provide additional information in h6: health effect - clinical code, health effect - impact code, medical device problem, component, type of investigation, investigation findings, investigation conclusions, and h10, and updated information in g1.Date of event in b3 was updated to the date of the original surgery.Investigation summary: since the complaint device was not returned, a physical evaluation of the device was not performed.However, without the device being returned or any photos provided, the complaint allegation is not confirmed.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, 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: jared engle ; 8009337001
• MDR Report Key: 16173397
• Report Number: 1220246-2023-06118
• Device Sequence Number: 14036261
• Product Code: MBI
• UDI-Device Identifier: 00888867286801
• UDI-Public: 00888867286801
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K150648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: 06/30/2026
• Device Model Number: H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
• Device Catalogue Number: AR-8978-CP
• Device Lot Number: 13634098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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