MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP MINI-MOD 1.5MM T PL 2H HD 6H SFT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	74441514
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the incision and identification of the fracture at the base of the proximal phalanx of the fifth finger of the left hand, it was decided to place the t-plate of 2x6 holes of the mini-mod 1.5 system.Two holes were removed to adapt it to the patient¿s anatomy, then, we started to fix it, a 1.1-gauge drill was used, a cortical screw was initially placed to attach the plate to the bone but this was not fixed in the correct way.For this reason, doctor decided to fix a blocked screw in another hole and change the first one by a blocked screw, but once changed, this was not blocked to the plate.Doctor decided to place the rest of screws, but all of them were in similar conditions, cortical screws are not adjusting when they are in contact and blocked screws that do not threaten in the plate, in spite of performing the steps for the placement of screw with guide and drill.Reduction of the fracture was verified and it was decided to leave the plate with the screws already implanted as support plate with immobilization of the phalanx.A 0-30 minutes delay was reported.
Additional Manufacturer Narrative
The associated complaint devices were not returned.Without the actual product involved our investigation cannot proceed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If the devices are received in the future, this complaint can be re-opened.We consider this complaint closed.

• Brand Name: VLP MINI-MOD 1.5MM T PL 2H HD 6H SFT
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8305928
• Report Number: 1020279-2019-00421
• Device Sequence Number: 1064493
• Product Code: HWE
• UDI-Device Identifier: 00885556491140
• UDI-Public: 00885556491140
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• 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): 06/16/2019

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 Catalogue Number: 74441514
• Initial Date Received by Manufacturer: 01/13/2019
• Supplement Date Received by Manufacturer: 01/13/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 06/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1