MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP MINI-MOD 1.5MM T PL 2H HD 6H SFT; PLATE, FIXATION, BONE

Model Number	74441514
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented an implant fracture.Upon reviewing the asymptomatic tac, it was noted that the plate failed and broke.The plate was removed and discarded.
Additional Manufacturer Narrative
The device, used for treatment was not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms no medical records were received however, it was reported that the patient presented with an implant fracture.Upon reviewing the asymptomatic tac, it was noted that the plate failed and broke.The plate was removed and discarded.The undated images show a persistent non-union of the 4th metatarsal which could contribute to the broken plate.It is uncertain how the fracture occurred and the patient impact beyond the pain and revision cannot be determined.Should additional medical documentation become available a thorough medical assessment can be rendered.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file as, insertion technique, excessive bending/ forming device, procedural/ user error, traumatic injury.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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 actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: VLP MINI-MOD 1.5MM T PL 2H HD 6H SFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9718861
• Report Number: 1020279-2020-00583
• Device Sequence Number: 361860
• Product Code: HRS
• UDI-Device Identifier: 00885556491140
• UDI-Public: 00885556491140
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K143050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 74441514
• Device Catalogue Number: 74441514
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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: Hospitalization; Required Intervention