MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 1.6 X 13MM, CORTICAL; PLATE, FIXATION, BONE

Model Number	LOW PROFILE SCREW, 1.6 X 13MM, CORTICAL
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/16/2020
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 mini cfs case one of the 1.6mm x 13mm cortical screws, ar-1816-06-13, was inserted and was a tad too long.When the surgeon went to remove it the head of the screw broke off.Broken piece will be returned for evaluation.Two screws were used in the case, lot 1065053 and lot 2684661.It is unknown which of the two was the one that broke.The body of the broken screw, approximately 11-12 mm, was left in the patient.The surgeon had drilled the appropriate screw hole as prep for insertion.The appropriate self retaining driver was used for insertion.The fracture was successfully reduced and completed.
Additional Manufacturer Narrative
Complaint confirmed, the screw broke.Only a 3mm long fragment was returned.Likely causes include prying/leveraging the device, continually applying torque if the implant is not moving.

• Brand Name: LOW PROFILE SCREW, 1.6 X 13MM, CORTICAL
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10217878
• Report Number: 1220246-2020-01936
• Device Sequence Number: 2120936
• Product Code: HRS
• UDI-Device Identifier: 00888867313255
• UDI-Public: 00888867313255
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K191326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2020

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, 1.6 X 13MM, CORTICAL
• Device Catalogue Number: AR-18716-13
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other