MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULATED SCREW 46MM 4.0; PLATE, FIXATION, BONE

Model Number 121846

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2020

Event Type  malfunction  

Event Description

It was reported that during surgery, after the screw was placed and the planes of motion were checked, when taking a post image, an implant deformity was seen.The device was removed and the procedure was completed with another screw (backup).Delay under 30 min and no injury to the patient.

Manufacturer Narrative

The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.Both screws are bent, rendering them inoperable.The devices were manufactured in 2018 and show signs of usage.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include device overload or an improper surgical technique.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: CANNULATED SCREW 46MM 4.0
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 10138197
• MDR Text Key: 194645918
• Report Number: 1020279-2020-02294
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 03596010064967
• UDI-Public: 03596010064967
• Combination Product (y/n): N
• PMA/PMN Number: K993106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 121846
• Device Catalogue Number: 121846
• Device Lot Number: 18LM07046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1