MAUDE Adverse Event Report: ARTHREX, INC. BIRDBEAK, 2.75MM, 45 DEGREE UP TIP; ORTHOPEDIC MANUAL SURG INSTR

Model Number	BIRDBEAK, 2.75MM, 45 DEGREE UP TIP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/01/2023, it was reported by a facility representative via sems-06072628 that an ar-11800 birdbeak broke.This occurred during a case.There was no additional information provided, and additional information has been requested.
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
Complaint is confirmed.Functional testing was not performed on the returned ar-11800 due to the damage to the device.Visual inspection noted the moving jaw of the device is broken.The most likely cause is attributed to misuse due to use error.

• Brand Name: BIRDBEAK, 2.75MM, 45 DEGREE UP TIP
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 18248365
• Report Number: 1220246-2023-09062
• Device Sequence Number: 12541709
• Product Code: LXH
• UDI-Device Identifier: 00888867003637
• UDI-Public: 00888867003637
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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 Model Number: BIRDBEAK, 2.75MM, 45 DEGREE UP TIP
• Device Catalogue Number: AR-11800
• Device Lot Number: 32642
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown