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	02/11/2021
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.
Event or Problem Description
It was reported that during a knee arthroscopy the screw thread has give way after the first turn.Therefore it was not possible to insert the implant.There was no harm for patient, operator or third party reported.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 25-feb-2021 dw: further information were provided that the screw had no grip after the first turn.After that the thread became detached and broke off.Everything was retrieved out of the patient.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-5028c-09 (no batch indicator present) was received for investigation.Visual inspection identified breakage at the two distal-most threads.The fragments generated during this event were not returned for analysis.It was identified that approximately 25.29 mm of the biocomposite screw remained.It was noted that the method of bone preparation used, as well as the bone quality encountered during the procedure, were not recorded.As such, the observed condition is most likely the result of improper bone preparation, off-axis insertion, and/or prying/leveraging.

• 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
• MDR Report Key: 11475556
• Report Number: 1220246-2021-02721
• Device Sequence Number: 3844130
• 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: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: BIO-COMP INTER-FERENCE SCRW
• Device Catalogue Number: AR-5028C-09
• Device Lot Number: 10784772
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/22/2021
• Patient Sequence Number: 1