MAUDE Adverse Event Report: ARTHREX, INC. SPEAR,TRCR 2.8MM FASTAK II; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SPEAR,TRCR 2.8MM FASTAK II
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during posterior stabilization surgery the 3mm shaver drill got stuck inside the drill guide when drilling into bone and breaks the shaver drill handpiece connector.Originally swapped the shaver drill but the guide damaged this drill also.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
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 not confirmed.Upon visual inspection, no problems were noted with the device.Upon functional testing, the included obturator and trocar were inserted as well as a suturetak.No device caught within the spear.

• Brand Name: SPEAR,TRCR 2.8MM FASTAK II
• 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: 14194550
• Report Number: 1220246-2022-04804
• Device Sequence Number: 14763722
• Product Code: LXH
• UDI-Device Identifier: 00888867024304
• UDI-Public: 00888867024304
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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: SPEAR,TRCR 2.8MM FASTAK II
• Device Catalogue Number: AR-1949
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 08/05/2022
• 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