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

Model Number	72823112S
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference case: (b)(6).
Event or Problem 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.
Additional Manufacturer Narrative
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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11952293
• Report Number: 1020279-2021-05033
• Device Sequence Number: 16409020
• Product Code: HRS
• UDI-Device Identifier: 03596010649300
• UDI-Public: 03596010649300
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K090675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1