MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP TI 2.4MM X 22MM CTX SCR T7 S-T; PLATE, FIXATION, BONE

Catalog Number 74402422

Device Problem Blocked Connection (2888)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2020

Event Type  malfunction  

Event Description

It was reported that during surgery the screws wouldn't lock into plate.Opened a new set and used the contents of that s&n set.No delay reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaints will be reopened.

• Brand Name: VLP TI 2.4MM X 22MM CTX SCR T7 S-T
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10101918
• MDR Text Key: 193132064
• Report Number: 1020279-2020-01903
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556346990
• UDI-Public: 885556346990
• Combination Product (y/n): N
• PMA/PMN Number: K132886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 74402422
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/07/2020
• Patient Sequence Number: 1