MAUDE Adverse Event Report: ARTHREX, INC. FASTTHREAD INTERFER SCRW DRIVER, 6MM, QC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	FASTTHREAD INTERFER SCRW DRIVER, 6MM, QC
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2021 it was reported by a facility representative via email that an ar-4019d-1 screw driver tip is broken.This occurred during a case, when the 6x20 screw would not fit over it.The surgeon completed the case going up to a bigger size screw.There was no patient effect reported.Additional information provided on 10/01/2021: procedure being done was an mpfl.No attachment was used.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified that the distal tip of the device had broken off.Due to the fractured state of the device, functional testing and accurate measurement analysis could not be performed.The root cause of the reported failure mode is undetermined.

• Brand Name: FASTTHREAD INTERFER SCRW DRIVER, 6MM, QC
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12659958
• Report Number: 1220246-2021-03823
• Device Sequence Number: 6078989
• Product Code: LXH
• UDI-Device Identifier: 00888867291935
• UDI-Public: 00888867291935
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: FASTTHREAD INTERFER SCRW DRIVER, 6MM, QC
• Device Catalogue Number: AR-4019D-1
• Device Lot Number: 47321822
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 10/28/2021
• Patient Sequence Number: 1