MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP TI 2.4MM X 20MM CTX SCR T7 S-T; PLATE, FIXATION, BONE

Catalog Number 74402420

Device Problem Blocked Connection (2888)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

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.

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

H10: smith & nephew, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, inc., or its employees, that the report constitutes an admission that the device, smith & nephew, inc., or its employees caused or contributed to the potential event described in this report.

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.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: VLP TI 2.4MM X 20MM CTX SCR T7 S-T
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis, tn TN 38116
• MDR Report Key: 10101605
• MDR Text Key: 193055445
• Report Number: 1020279-2020-01902
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556346891
• UDI-Public: 885556346891
• 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,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 74402420
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/29/2020
• Supplement Dates Manufacturer Received: 05/04/2020; 09/06/2020
• Supplement Dates FDA Received: 06/03/2020; 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1