MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTER-FERENCE SCRW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP INTER-FERENCE SCRW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2023
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 the screw had a defective thread.It was noticed before the surgery.There was no harm for patient, operator or third party.Swit (b)(6) 2023: the incident occured during an anterior cruciate ligament replacement plastic surgery.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Event or Problem Description
It was reported that the screw had a defective thread.It was noticed before the surgery.There was no harm for patient, operator or third party.Update swit 09-apr-2023: the incident occurred during an anterior cruciate ligament replacement plastic surgery.The tip of the screw broke off inside the patient.The broken piece was retrieved from patient.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update swit 12-apr-2023: two screws were returned for evaluation, one of them has a defective thread and with the second screw the tip is missing.
Additional Manufacturer Narrative
The complaint is confirmed.Two unpackaged ar-5028c-09 batch number 14996351 were received for investigation.Visual evaluation found the bio screws are deformed.One screw is missing the geometry at the distal end close to the tip/end.The second screw was broken at the distal end close to the tip/end.The reported failure is most likely caused by; 1.Exposing the screws to high temperatures.2.As a result of user error: failure to engage the screw completely may result in damage to the implant, or 3.Manufacturing issues.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.

• Brand Name: BIO-COMP INTER-FERENCE SCRW
• 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: 16875586
• Report Number: 1220246-2023-06675
• Device Sequence Number: 12218107
• Product Code: MAI
• UDI-Device Identifier: 00888867035331
• UDI-Public: 00888867035331
• 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): 10/02/2023

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: 07/31/2026
• Device Model Number: BIO-COMP INTER-FERENCE SCRW
• Device Catalogue Number: AR-5028C-09
• Device Lot Number: 14996351
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2023
• Supplement Date Received by Manufacturer: 04/09/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown