MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP 2.7MM S-T LOCK CORT SCR 12MM STER; PLATE, FIXATION, BONE

Model Number 72823112S

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference (b)(4).

Event Description

It was reported that, vlp 2.7mm s-t lock cort scr 12mm ster screws were not locking.It was unknown if this occurred during surgery or not; therefore, patient involvement has not been confirmed.

Manufacturer Narrative

H6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure.The device has signs of damage from attempted use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.At this time, we have no 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 a fit/sizing issue or surgical technique.This issue was evaluated through our internal nonconformance process and determined to be isolated at this time.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: VLP 2.7MM S-T LOCK CORT SCR 12MM STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11952309
• MDR Text Key: 254807642
• Report Number: 1020279-2021-05034
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 03596010649300
• UDI-Public: 03596010649300
• Combination Product (y/n): N
• PMA/PMN Number: K090675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

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: Health Professional
• Device Model Number: 72823112S
• Device Catalogue Number: 72823112S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 08/24/2021
• Supplement Dates FDA Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1