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

Model Number	71158103
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9532181
• Report Number: 1020279-2019-04672
• Device Sequence Number: 14024235
• Product Code: JDS
• UDI-Device Identifier: 00885556693780
• UDI-Public: 00885556693780
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 71158103
• Device Catalogue Number: 71158103
• Device Lot Number: 18LT13075
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 12/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR