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

Catalog Number	71158104
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a distal radius operation, two distal screw holes didn´t work properly way, as the locking screws didn´t locked into two of the distal holes on the right side of the evos volar plate 4h left std std ti 56mm.The evos volar plate 4h left std std ti 56mm was inspected and it was noticed that those two holes were damaged.Surgery was resumed with a back-up plate, after a significant delay.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Results of investigation: the associated device was returned and evaluated.The visual inspection revealed the screw holes are stripped.A dimensional evaluation performed on the device revealed compliance with the specified tolerances.It is evident that the damage to the star tab likely occurred during the insertion or extraction of the locking screw on several hole locations.The possibility exists that incorrect screw placement or excessive torque caused the damage, leading to the complete loss of star tabs.In conclusion, the damage to the star tab and hole did not originate during the part's machining process.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed a similar event for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.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 as a warning.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 evidence to conclude that the product failed to meet specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.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.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: 18237747
• Report Number: 1020279-2023-02361
• Device Sequence Number: 11569485
• Product Code: HRS
• UDI-Device Identifier: 00885556693827
• UDI-Public: 00885556693827
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K210837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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 Catalogue Number: 71158104
• Device Lot Number: 21JT54766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• 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
• Patient Sex: Unknown