MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS VOLAR PLATE 3H LEFT STD TI 48MM; NAIL, FIXATION, BONE

Model Number 71158103

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Event Description

It was reported that during surgery an evos wrist ti 4h std l volar distal radius plate (71158104) was used with a 16mm locking screw (74412416), but the screw fell through the plate.Then, an evos wrist ti 3h std l volar distal radius (plate 71158103) with a new 16mm screw (74412416) was tried and it had the same issue.The surgery was completed using an old-style volar distal radius set.Additionally, 11mm cortex screw (74402411) was found to have the same failure as well.For this event, there was a delay greater than 30 min and the patient was not injured.

• Brand Name: EVOS VOLAR PLATE 3H LEFT STD TI 48MM
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 9532181
• MDR Text Key: 177162471
• Report Number: 1020279-2019-04672
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556693780
• UDI-Public: 00885556693780
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2020

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
• Device Operator: Health Professional
• Device Model Number: 71158103
• Device Catalogue Number: 71158103
• Device Lot Number: 18LT13075
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR