MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP TI 2.4MM X 17MM LCK SCR T7 S-T; PLATE, FIXATION, BONE

Model Number	74412417
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a right 3h standard plate in bilateral wrist case, the 17mm locking screw (vlp ti 2.4mm x 17mm lck scr t7 s-t ns) went through the plate (evos volar plate 3h right std ti 48mm) in the distal most hole on the ulnar side.The physician was unable to back it out and already had other screws in the distal fragment so couldn't remove the plate to remove the screw.Surgeon isn't really concerned but it needs to be reported.The surgeon assumed that the tabs inside the hole bent while inserting the screw and did not lock onto the screw allowing it to pass through.The surgery finished with the same device.No injury or significant delay reported.Operative reports are not available.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the device, could not be returned for evaluation.However, the provided electronic photocopied fluoro/x-ray images were reviewed by the clinical/medical team and revealed that the screw passed-through the plate.The clinical/medical investigation concluded that, based on the information provided, no clinical factors have been definitively concluded to have contributed to the reported event; however, user technique could not be ruled out as a possible contributing factor.The surgical technique notes to limit engagement of va-locking mechanisms to ¿twice¿ during screw insertion.The assessed patient impact is the retained screw which passed-through the plate and the 0-30-minute surgical extension, and although unlikely, possible migration and local irritation cannot be ruled out.No further medical assessment can be rendered at this time.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 mini-fragment plating system revealed in warnings section that that improper positioning may result in loosening, bending, cracking, or fracture of the device or bone or both.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 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 user technique.The contribution of the device to the reported event could be corroborated as the fluoro/x-ray images reveals that the screw did not lock into the hole of the plate and pass through it.Based on this investigation, the need for corrective action is not indicated.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: VLP TI 2.4MM X 17MM LCK SCR T7 S-T
• 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: 15214391
• Report Number: 1020279-2022-03663
• Device Sequence Number: 5974917
• Product Code: HRS
• UDI-Device Identifier: 00885556348697
• UDI-Public: 00885556348697
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K132886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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: 74412417
• Device Catalogue Number: 74412417
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/12/2022
• 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: Female