MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN EVOS PLATING SCREW; SCREW, FIXATION, BONE

Model Number 71158104

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Rupture (2208)

Event Date 01/19/2022

Event Type  Injury  

Event Description

It was reported that, during an internal fixation surgery, when inserting an screw through the plate, the head went straight through the plate and did not engage with the locking petals.Surgery was resumed, after a non-significant delay, with a change in the surgical technique.The plate and screw was removed before an additional bone hole was made in order to correctly fixate the same plate again.The screw was explanted and discarded.

Manufacturer Narrative

The device was not returned for evaluation but the pictures were reviewed, and it was confirmed that the head of the screw went straight through the plate and did not engage with the locking petals.The clinical/medical investigation concluded that, based on the information provided, the surgeon removed the screw and completed the case with the same plate.However, the surgeon did not use that screw hole in the plate, an additional bone hole was used with a different screw to fix the plate without repositioning the plate.Per subsequent e-mail, ¿the surgeon thinks that the plate was either faulty, or that he used too much force/torque when inserting the screw that it threaded the locking petals and went through the plate.¿ it was reported, the surgery resumed, after a non-significant delay, with a change in the surgical technique.Reportedly, the explanted unkn evos plating screw will not return for evaluations as it was disposed of by the surgeon the end of the case.Without the unknown explanted screw for evaluations, the causal relationship between the s&n device and the reported issue cannot be confirmed.The impact to the patient beyond that which has already been reported, cannot be confirmed nor concluded.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant clinical information be provided, this case would be re-assessed.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 incident could be corroborated as a change in the surgical technique was needed to complete the surgery.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.

Manufacturer Narrative

Additional information: d7a, g(contact office), g1 (phone number), g2 (report source), h8.Corrected data: h4 (manufactured date is not known for screw), h6 (type of investigation, investigation findings, investigation conclusions).Updated results of investigation: the devices were not available for evaluation; therefore, a device analysis could not be performed.However, the clinical/medical investigation concluded that, the provided image confirmed the head went through the plate.However, it does not aid in determining the root cause of the reported failure.Per the complaint details, currently we are unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Based on the information provided, the surgeon did not use the screw hole in the plate, an additional bone hole was used with a different screw to fix the plate without repositioning the plate.Per subsequent e-mail, ¿the surgeon thinks that the plate was either faulty, or that he used too much force/torque when inserting the screw that it threaded the locking petals and went through the plate.It is unknown if the instructions for use for the evos plating system was adhered to.A photo of chart sticks, was provided for review.According to the report, the surgery resumed, after a non-significant delay, with a change in the surgical technique.Reportedly, the explanted unkn evos plating screw will not return for evaluations as it was disposed of by the surgeon the end of the case.Without the unknown explanted screw for evaluations, the causal relationship between the s&n device and the reported issue cannot be confirmed.The impact to the patient beyond that which has already been reported, cannot be confirmed nor concluded.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant clinical information be provided, this case would be re-assessed.Based on the evidence provided, the unsatisfactory experience could be confirmed.The evos plaiting screw specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file, prior actions review and product prints review could not be performed.A review of the production order for the evos volar plate did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the evos volar plate 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 in warnings section 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 has been identified.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 products 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.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: UNKN EVOS PLATING SCREW
• Type of Device: SCREW, 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: 14165533
• MDR Text Key: 289726595
• Report Number: 1020279-2022-01897
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00885556693827
• UDI-Public: 00885556693827
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

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?: No
• Device Model Number: 71158104
• Device Catalogue Number: 71158104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EVOS PLATE # 71158104, LOT 21CT48403
• Patient Outcome(s): Required Intervention