MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS VOLAR PLATE 4H LEFT STD STD TI 56MM; PLATE, FIXATION, BONE

Model Number	71158104
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference number: (b)(4).
Event or Problem Description
It was reported that, during a trauma surgery, two locking screws went through the distal holes of the evos volar plate 4h left std, std ti 56mm device.The procedure was resumed, after a significant delay, with the same device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the device, could not be returned for evaluation.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.We consider this investigation closed.

• Brand Name: EVOS VOLAR PLATE 4H LEFT STD STD TI 56MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15787668
• Report Number: 1020279-2022-04767
• Device Sequence Number: 20270671
• Product Code: HRS
• UDI-Device Identifier: 00885556693827
• UDI-Public: 00885556693827
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

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 Model Number: 71158104
• Device Catalogue Number: 71158104
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown