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

Model Number	71158203
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a wrist case, a locking screw pushed through the 71158203 r 3h std volar plate.The tabs were completely gone and were retrieved outside the patient.Dr.Used the va guide correctly and only drilled at an appropriate angle.He had to switch to a 4 hole plate to finish the case which we had available to him.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.Several of the fixation holes in the device were heavily damaged from attempted use, rendering the device inoperable.A dimensional inspection was attempted but the device was too damaged from attempted use to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include a fit/ sizing issue or a procedural error.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: EVOS VOLAR PLATE 3H RIGHT STD TI 48MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10258528
• Report Number: 1020279-2020-03051
• Device Sequence Number: 2432761
• Product Code: HRS
• UDI-Device Identifier: 00885556693797
• UDI-Public: 00885556693797
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K181533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71158203
• Device Catalogue Number: 71158203
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 06/29/2021
• 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: Required Intervention