MAUDE Adverse Event Report: ARTHREX, INC. Ø9X 30MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø9X 30MM BC IF SCRW, VENTED
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
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 surgery the graft broke in the joint because the screw might have been too sharp.The broken graft was retrieved from patient.The surgery could not be completed because the graft broke, so a second surgery will be performed on (b)(6) 2023.Update (b)(6) 2023 nroemer: further information revealed that when the graft was implanted the surgeon checked the tension and discovered that the graft was loose.When the surgeon pulled on the graft, it came along up/in the joint.The screw and the part that was in the tibia tunnel were completely removed.The rest of the graft in the joint and the femur tunnel was shaved away.An acl button from ar-1588rt is still in the patients lateral.The quadruple semi t and gracilis graft was fixated with an acl tightrope (ar-1588rt) at the proximal part of the graft and also sutured distal with suturetape (ar-7500).The distal part of the graft was fixated with ar-4030c-09.
Additional Manufacturer Narrative
Complaint is confirmed.Visual inspection identified the holes, and threads of the fastthread¿ biocomposite¿ interference screw 9 x 30 mm had flashes and scratches.The edges of the treads had deformations due to the scratches.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: Ø9X 30MM BC IF SCRW, VENTED
• 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: 17714221
• Report Number: 1220246-2023-07834
• Device Sequence Number: 12485396
• Product Code: MAI
• UDI-Device Identifier: 00888867277663
• UDI-Public: 00888867277663
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K180662
• 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): 05/24/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: Ø9X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-09
• Device Lot Number: 15076175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown