MAUDE Adverse Event Report: SMITH & NEPHEW, INC. P-L VLP 3.5MM PM-P TIBIA LK PL 7H L 98MM; PLATE, FIXATION, BONE

Model Number	72820107
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, it was decided to place a medial plate (posteromedial) and another side plate of the same system 3.5 vlp.After communicating the doctor that the plate was blocked with 15° angulation, it was processed to drill with the drill of 2.7 to locate screws, but after performing it several times and in different holes, no screw locked in the plate.It is decided to put on this plate only cortex screws.It is unknown if there were any delays in the procedure.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that, without the requested clinically relevant documentation, a thorough medical investigation could not be performed.Per the peri-loc vlp va lps surgical technique,¿locking screws can be angled and locked up to 15°in any direction and accepts 3.5mm cortex or locking screws and/or 5.0mm osteopenia screws¿for the 3.5mm locking screw insert the universal drill guide handle with 2.7mm variable angle drill guide into the desired screw hole.The drill guide is correctly aligned when its star-shaped tip engages with the five tabs in the hole.Adjust screw trajectory by rotating the tip of the variable angle drill guide 360° within the plate hole and up to 15° in any direction.Drill accordingly with either the short or long 2.7mm drill bit depending upon plate type and location¿.The root cause and patient impact could not be assessed.Should relevant clinical documentation become available, the medical assessment may be re-evaluated at that time.A review of complaint history did not reveal additional complaints for the listed device.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 improper surgical technique or mating feature sizing.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: P-L VLP 3.5MM PM-P TIBIA LK PL 7H L 98MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9535911
• Report Number: 1020279-2019-04744
• Device Sequence Number: 3603356
• Product Code: HRS
• UDI-Device Identifier: 00885556067536
• UDI-Public: 00885556067536
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K062216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 72820107
• Device Catalogue Number: 72820107
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 04/15/2020
• 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