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

Model Number	72823112
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that once the hallux with pins was reduced, the doctor located the left mtp plate (72824015) following the indicated surgical technique, located the drill guide drill with the 2.0 drill perpendicular to the bone, measured and located the 2.7 cortical screw x14.For the following screws and using the same surgical technique but with the variable angle guide, surgeon proceeded to place the locked screws and noted that they did not lock on the plate, change measurements, change direction and even so they gave insufficient fixation.Finally, surgeon decided to perform the arthrodesis with s&n cannulated screws, it is clear that no part of the implant remained inside the patient and the problem could be satisfactorily resolved.The patient health conditions is stable and no damage occurred to the patient due to this event.Delay of (0 30) minutes reported.

• Brand Name: VLP 2.7MM S-T LOCK CORT SCR 12MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9953502
• Report Number: 1020279-2020-01284
• Device Sequence Number: 2596617
• Product Code: HRS
• UDI-Device Identifier: 03596010623218
• UDI-Public: 03596010623218
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K090675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

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: 72823112
• Device Catalogue Number: 72823112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/14/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 02/02/2021
• 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