MAUDE Adverse Event Report: ARTHREX, INC. INTBRACE LGMNT REPR AUGMNT KIT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	INTBRACE LGMNT REPR AUGMNT KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/03/2023, it was reported by an arthrex employee via email that an ar-1678-cp implant system screw broke right after inserting it into the patient.This was discovered during an elbow internal brace.The case was completed by using a new ar-1678-cp.
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
Review of this complaint confirmed the event summary code selection, and an investigation was performed as required.The complaint device was not available for investigation, however, picture(s) were provided and used for investigation.The investigation confirmed the reported condition.The probable cause of the event was able to be determined and found to be a use error.The investigation did not change the potential harm(s) identified.Complaint trending for this event will be performed per (b)(4).

• Brand Name: INTBRACE LGMNT REPR AUGMNT KIT
• 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: 17662421
• Report Number: 1220246-2023-07719
• Device Sequence Number: 7123989
• Product Code: MAI
• UDI-Device Identifier: 00888867020887
• UDI-Public: 00888867020887
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: INTBRACE LGMNT REPR AUGMNT KIT
• Device Catalogue Number: AR-1678-CP
• Device Lot Number: 15089663
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown