MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 7.0MM COMPRESSION SCREW DRILL; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 71674034

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Internal Organ Perforation (1987); Perforation (2001)

Event Date 06/18/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during an internal fixation surgery, a 7.0mm compression screw drill did not run parallel onto the lag screw driver, rendering the surgeon unable to insert the screw.Therefore, surgeon had to remove the anti-rotation bar, turn the screw back completely, and then pull on the rod with force because it was jammed in the sleeve or in the femur due to the incorrect drilling direction.It is unknown if this incident caused any delay.Surgery was finished with the same device.No further complications were reported.The instruments were checked later, and no error was found.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation, but the pictures of the instrument were reviewed, and no error was found, therefore the event could not be confirmed.The clinical/medical investigation concluded that, although it was reported that the patient ¿probably¿ had damage to the cancellous bone during this procedure, it is unknown if this is just a suspicion or a fact.Without the supporting information the root cause of the event cannot be confirmed, nor concluded that the issue was caused by a mal performance of the device or the surgical technique.It was reported that the instruments were checked later, and no problem was found.Further impact to the patient cannot be determined with the lack of information.No further clinical/medical investigation is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device 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.Possible causes could include but not limited to surgical technique used or user/procedural variance.The contribution of the device to the reported event could not be corroborated, as the instruments were checked later, and no error was found.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.Internal complaint reference number: (b)(4).

• Brand Name: 7.0MM COMPRESSION SCREW DRILL
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 14990942
• MDR Text Key: 295765193
• Report Number: 1020279-2022-03291
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 03596010560544
• UDI-Public: 03596010560544
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71674034
• Device Catalogue Number: 71674034
• Device Lot Number: 18LNG0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other