MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CORTEX HEX SCREW S-T 4.5 X 40 MM STRL; PLATE, FIXATION, BONE

Catalog Number	3571149740
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a screw broke in patient in not particular hard bone.
Event or Problem Description
It was reported that a screw broke in patient in not particularly hard bone and the surgery had a delay longer than 30 minutes.
Additional Manufacturer Narrative
The associated complaint device was returned for evaluation.No relevant supporting clinical information has been provided to assist with a clinical investigation, and there is no report of the patient's current condition.Therefore, based on insufficient information a clinical assessment cannot be performed at this time.The stated failure mode was confirmed through a visual inspection of the returned 4.5mm x 40mm self-tapping cortex screw hex.The cortex screw is broken.The broken fragment was not returned with this complaint.Based on this investigation, it was concluded that the cortex hex screw fractured due to ductile torsional overload.An overload fracture can occur if the mechanical loads applied to the threaded portion of the screw exceed the strength of the material.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: CORTEX HEX SCREW S-T 4.5 X 40 MM STRL
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7409729
• Report Number: 1020279-2018-00742
• Device Sequence Number: 18875245
• Product Code: HRS
• UDI-Device Identifier: 03596010499288
• UDI-Public: 03596010499288
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K993106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2018

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 Catalogue Number: 3571149740
• Device Lot Number: 17KT93780
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 03/16/2018; 03/16/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 04/12/2018; 08/08/2018
• 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