MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP 2.7MM MTP NARROW PLATE RIGHT 3H; PLATE, FIXATION, BONE

Model Number	71934819
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the plate broke through the hole next to the compression slot.
Additional Manufacturer Narrative
Results of investigation: the devices, used in treatment, were not returned for evaluation.A clinical analysis indicated it was reported that the plate has broken through the hole next to the compression slot.The surgeon believes this is the 3rd or 4th plate this has happened to.X-ray provided shows a plate spanning the metatarsophalangeal joint of the great toe it is unknown what is being treated or where a fracture is but this not indicated to stabilize or fuse a joint there is a single screw across the joint along with this plate but micro motion is probably the root cause of the reported repeated breakage of plates at this location.No other medical records or evidence of this complaint has been received.The reported event cannot be assessed and a thorough medical assessment cannot be performed.When additional medical documentation has been provided for this complaint it will be re-evaluated and a thorough medical assessment rendered.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions of use for the product was conducted.Factors and/or some potential probable causes that could include but not limited material, design inadequate, untended use, patient noncompliant, or non-union.Without the return of the actual product involved, our investigation cannot proceed.

• Brand Name: VLP 2.7MM MTP NARROW PLATE RIGHT 3H
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9720372
• Report Number: 1020279-2020-00611
• Device Sequence Number: 11351142
• Product Code: HRS
• UDI-Device Identifier: 00885556336793
• UDI-Public: 00885556336793
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71934819
• Device Catalogue Number: 71934819
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention