MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERFSCRW,FULL THD; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP INTERFSCRW,FULL THD
Medical Device Problem Codes	Defective Device (2588); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery the thread on the screw has twisted off.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device (ar-1380tc).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
Additional information: d9, g3, h6.-complaint allegation is not confirmed.-one unpackaged ar-1370tc full thread cannulated biocomposite interference screw was received for evaluation.-visual inspection noted no problems with the device.The device was further visually inspected under a magnifier and no damage was observed to the thread of the device.No problem found.-functional testing was performed with an ar-1996cd biocomposite interference screwdriver batch number: (b)(4) and it was observed that the ar-1370tc full thread cannulated biocomposite interference screw sat flush against the driver.No problem found.-no problem found.-refer to investigation photos.

• Brand Name: BIO-COMP INTERFSCRW,FULL THD
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 17843038
• Report Number: 1220246-2023-08036
• Device Sequence Number: 4350061
• Product Code: MAI
• UDI-Device Identifier: 00888867014725
• UDI-Public: 00888867014725
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071176
• 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): 07/08/2024

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: BIO-COMP INTERFSCRW,FULL THD
• Device Catalogue Number: AR-1370TC
• Device Lot Number: 12035884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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