MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS VOLAR PLATE 7H L STD 100MM; PLATE, FIXATION, BONE

Model Number	72468107N
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an internal fixation surgery, the surgeon attempted to insert a locking screw perpendicular to the evos distal radius volar plate 7 hole left standard 100mm but it did not lock, it kept spinning.The locking screw was removed and another screw attempted into the same screw hole and it went through the plate.Another locking screw was placed in an adjacent screw hole.Surgery was resumed, after a non-significant delay, with the same device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, the provided fluoroscopic images were reviewed.However, they do not aid in the clinical/medical investigation of the reported events.Based on the limited information provided, after a non-significant delay, the surgery was resumed and completed with the same device.No further complications were reported.Therefore, no further clinical assessment is warranted at this time.Should any additional relevant clinical information be provided, this complaint would be re-assessed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for evos¿ plating system revealed that it is extremely important to select the appropriate size and type components.Failure to use the largest possible components or improper positioning may result in loosening, bending, cracking, or fracture of the device or bone or both.Besides, warnings section stablishes that this device should not be used if package or product is damaged.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.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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 the device or 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 7H L STD 100MM
• 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: 14246937
• Report Number: 1020279-2022-02049
• Device Sequence Number: 4445526
• Product Code: HRS
• UDI-Device Identifier: 00885556713624
• UDI-Public: 00885556713624
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

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: 72468107N
• Device Catalogue Number: 72468107N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown