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

Model Number	BIO-COMP INTER-FERENCE SCRW
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
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 anterior cruciate ligament surgery during the first turns of the screw, when inserting, the screw thread on the screw head twisted off directly.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with part number ar-5035tc-09.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-5028c-08 was received for investigation.Visual inspection identified breakage across the distal-most threads of the returned biocomposite screw.The method used to prepare the bone socket during the procedure, as well as the bone quality encountered, were not provided.A probable cause is attributed to improper bone preparation.

• 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: 14192646
• Report Number: 1220246-2022-04774
• Device Sequence Number: 4975291
• Product Code: MAI
• UDI-Device Identifier: 00888867035324
• UDI-Public: 00888867035324
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/25/2022

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: 05/31/2025
• Device Model Number: BIO-COMP INTER-FERENCE SCRW
• Device Catalogue Number: AR-5028C-08
• Device Lot Number: 13589232
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown