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

Catalog Number	74402420
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis, tn TN 38116
• MDR Report Key: 10101605
• Report Number: 1020279-2020-01902
• Device Sequence Number: 14331051
• Product Code: HRS
• UDI-Device Identifier: 00885556346891
• UDI-Public: 885556346891
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Catalogue Number: 74402420
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 05/04/2020; 09/06/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 06/03/2020; 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1