MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW,CORTICAL,3.5X16MM,DRP; SCREW, FIXATION, BONE

Model Number	LOW PROFILE SCREW,CORTICAL,3.5X16MM,DRP
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/03/2019
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 case, the surgeon was inserting the titanium 3.5 cortical low profile screw, ar-8735-16, through the compression slot of a 6-hole titanium reconstruction plate.As he reached the far cortex, he continued to try and gain additional compression when the head of the screw broke from the shaft of the screw.The head of the screw was retrieved but the screw is still in the patient stuck within the cortices of bone.Patient is a male, (b)(6).Additional information requested.Additional information provided 6/6/2019: this occurred during a radial shaft fracture and the head of the screw was removed in default of compressing the plate to bone.The patient was (b)(6) with consequentially strong cortical bone in the radius.Rep does not have x-rays but the screw shaft was left in the proximal aspect of the oblong slot of a 6-hole titanium reconstruction plate.No graft was being used in this plating construct.

• Brand Name: LOW PROFILE SCREW,CORTICAL,3.5X16MM,DRP
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8734556
• Report Number: 1220246-2019-01162
• Device Sequence Number: 1889634
• Product Code: HWC
• UDI-Device Identifier: 00888867288324
• UDI-Public: 00888867288324
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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 Model Number: LOW PROFILE SCREW,CORTICAL,3.5X16MM,DRP
• Device Catalogue Number: AR-8735-16
• Device Lot Number: 2658231
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/26/2019
• 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
• Patient Age: 32 YR