MAUDE Adverse Event Report: ARTHREX, INC. Ø10X 30MM BC IF SCRW, VENTED; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	Ø10X 30MM BC IF SCRW, VENTED
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/13/2022
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
It was reported that during an anterior cruciate ligament (acl) surgery using standard technique tightrope in femur and screw in the tibia with graft diameter was 9.5 mm after compression, the screw broke during fixation.50% of the screw remains inside the tibial tunnel.It was not retrieved from patient.A second fixation of the graft done with swivelock 5.5 mm.The tibial tunnel was done 9.5 mm.A 10 mm tapping was done and graft passed successfully.A fast thread screw size 10x30 was opened and screwdriver ar-1996cd was used for the procedure.The purchasing of the screw to the screw driver was not complete.It was not necessary to switch the surgical technique or do a second surgery.Update 17-jun-2022 additional information received: the screwdriver goes through the screw only halfway.It should go more inside the screw to fit completely.

• Brand Name: Ø10X 30MM BC IF SCRW, VENTED
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 14914720
• Report Number: 1220246-2022-05167
• Device Sequence Number: 1990021
• Product Code: MAI
• UDI-Device Identifier: 00888867277670
• UDI-Public: 00888867277670
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K180662
• 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
• Report Date (Section B): 07/05/2022

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 Expiration Date: 09/30/2025
• Device Model Number: Ø10X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-10
• Device Lot Number: 14243892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 07/05/2022
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown