MAUDE Adverse Event Report: ARTHREX, INC. BIRDBEAK, 2.75MM, 22 DEGREE UP TIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	BIRDBEAK, 2.75MM, 22 DEGREE UP TIP
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This is a conversion from cc195923, line 299787.An customer update was received which made a repair to a complaint.The customer stated the tip broke-off during a surgery.Further information requested.No new information given at this time.21-oct-2022 update: further information were provided that the reported event occurred during a shoulder arthroscopy.The surgery could be finished successfully and most likely the broken part remained attached to the device or could be retrieved.
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 confirmed.Upon visual inspection, it was noted that the moving jaw was broken off.The broken piece was not returned for investigation.The cause remains undetermined, although a probable cause is attributed to the application of leveraging forces on the distal end of the device.

• Brand Name: BIRDBEAK, 2.75MM, 22 DEGREE UP TIP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15657382
• Report Number: 1220246-2022-05647
• Device Sequence Number: 6377200
• Product Code: LXH
• UDI-Device Identifier: 00888867003774
• UDI-Public: 00888867003774
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/05/2023

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, 22 DEGREE UP TIP
• Device Catalogue Number: AR-11890
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown