MAUDE Adverse Event Report: ARTHREX, INC. SCREW, CANCELLOUS; PLATE, FIXATION, BONE

Model Number	SCREW, CANCELLOUS
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/12/2021
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 distal tibial osteotomy, after the ar-13715-09.0, hto plate was seated, as the surgeon was inserting the ar-13280-40, screw, it was noticed that the bushing on the plate came loose.The surgeon removed the plate and screw, the bushing was attached to the screw.The case was completed using ar-13100.09.There was 30-45 minutes added to the procedure requiring additional anesthesia.
Additional Manufacturer Narrative
Complaint confirmed, the bushing was found disassembled, however no abnormality was observed on the screw that may have contributed to the event.

• Brand Name: SCREW, CANCELLOUS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11648284
• Report Number: 1220246-2021-02881
• Device Sequence Number: 19719399
• Product Code: HRS
• UDI-Device Identifier: 00888867010543
• UDI-Public: 00888867010543
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K032187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: SCREW, CANCELLOUS
• Device Catalogue Number: AR-13280-40
• Device Lot Number: 11381699
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other