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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
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
It was reported that the tip at the front part broke off intraoperatively.There was no harm for patient, operator or third party reported.Update swit (b)(6) 2023: a labrum refixation surgery was performed.The surgery was finished successfully with a lasso.The device broke off inside the patient.The broken piece was retrieved from patient.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint is confirmed.Visual evaluation noted the cutter tip is broken off and some discoloration on the device.No broken pieces were returned for investigation.Functional testing was not performed due to the damage to the device.The most probable cause is by applying excessive force while grasping and manipulating tissue or when applying excessive leveraging forces.

• 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: 17611230
• Report Number: 1220246-2023-07613
• Device Sequence Number: 7364796
• Product Code: LXH
• UDI-Device Identifier: 00888867003637
• UDI-Public: 00888867003637
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• PMA/510(K) Number: EXEMPT
• 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): 11/14/2023

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 Model Number: BIRDBEAK, 2.75MM, 45 DEGREE UP TIP
• Device Catalogue Number: AR-11800
• Device Lot Number: 27273
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 11/14/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown