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	Foreign Body In Patient (2687)
Date of Event	01/18/2021
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.
Event or Problem Description
It was reported that spear for 2.8 mm fastak, ar-1949, was being used in a bankhart repair.During use, when the surgeon drilled into the glenoid, pieces of metal were generated and fell into the patient's body.The surgeon cleaned inside of the joint, but could not confirm whether all the metal pieces were removed.Ar-1250ft was also used when drilling.The surgery was completed by using new products of same part no.
Additional Manufacturer Narrative
Complaint confirmed.Circumferential abrasion marks were observed on the id surface of the spear, near the distal end.However, no burrs or metal pieces were found.The inner diameters of the spear were found to meet specifications.The returned obturator were found to meet specifications and were free of abrasion damage.They fit within the spear without difficulty or grinding.The cause of the event is undetermined, but a likely cause is prying/leveraging the device during use.

• 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: 11251314
• Report Number: 1220246-2021-02512
• Device Sequence Number: 19702281
• Product Code: LXH
• UDI-Device Identifier: 00888867024304
• UDI-Public: 00888867024304
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 11/23/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown