MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 1.6 X 7MM, CORTICAL; PLATE, FIXATION, BONE

Model Number	LOW PROFILE SCREW, 1.6 X 7MM, CORTICAL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2021
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.
Event or Problem Description
It was reported that during a (b)(6) 2021 procedure the surgeon drilled for a 1.6 x 7 cortical screw.Upon implanting the screw through the plate the head of the screw broke off.Additional information obtained 1/19/21: procedure was a metacarpal fracture.The lot number of the screw is unknown.All pieces of the screw were fully retrieved and accounted for.The surgeon kept the remaining body of the screw in the patient and continued to drill and fill the plate.
Additional Manufacturer Narrative
It was reported that the screw broke during the procedure.The reported event is confirmed upon investigation of the returned picture.The picture provided shows an unknown screw that has been bent, and fractured just below the head of the screw.Further evaluation cannot be performed since the product was not returned.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion.

• Brand Name: LOW PROFILE SCREW, 1.6 X 7MM, CORTICAL
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11251289
• Report Number: 1220246-2021-02511
• Device Sequence Number: 14321910
• Product Code: HRS
• UDI-Device Identifier: 00888867313194
• UDI-Public: 00888867313194
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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 Model Number: LOW PROFILE SCREW, 1.6 X 7MM, CORTICAL
• Device Catalogue Number: AR-18716-07
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 02/04/2021
• 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