MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 32.5MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645032
Medical Device Problem Codes	Connection Problem (2900); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Case (b)(4).
Event or Problem Description
It was reported that during intertan nail surgery, the most distal screw interfered with the outside the screw hole on the nail.Then the connecting part on the screw head was stripped while the surgeon attempting to remove the screw.Finally, the surgery completed without removing the screw.The screw left inside the patient.60 minutes surgical delay.No serious injury reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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: TRIGEN LOW PROFILE SCREW 5.0MM X 32.5MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10985256
• Report Number: 1020279-2020-07339
• Device Sequence Number: 14535528
• Product Code: HSB
• UDI-Device Identifier: 00885556215647
• UDI-Public: 00885556215647
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 71645032
• Device Catalogue Number: 71645032
• Device Lot Number: 20CM01944
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 07/01/2021
• 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: Hospitalization; Required Intervention