MAUDE Adverse Event Report: SMITH & NEPHEW, INC. V-D-R LK PL STD HD 9H R 135MM; PLATE, FIXATION, BONE

Model Number	71803128
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during the operation of a distal radius combined with cadre fracture, the steel plate broke during shaping.Procedure continued with a backup device from smith and nephew.It is unknown if there was a delay or the outcome of the patient.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was fractured into three pieces, rendering the device inoperative.All fractured components of the device were returned.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 and potential harm was previously identified.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file, include but not limited to excessive forces applied to implant and inadequate design.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 future complaints and investigate as necessary.

• Brand Name: V-D-R LK PL STD HD 9H R 135MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10836616
• Report Number: 1020279-2020-06423
• Device Sequence Number: 3798994
• Product Code: HRS
• UDI-Device Identifier: 03596010583031
• UDI-Public: 03596010583031
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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 Expiration Date: 10/09/2022
• Device Model Number: 71803128
• Device Catalogue Number: 71803128
• Device Lot Number: 17KM07351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1