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

Model Number	71674034
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Perforation (2001)
Date of Event	06/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2022-03291
• Device Sequence Number: 13887579
• Product Code: KTT
• UDI-Device Identifier: 03596010560544
• UDI-Public: 03596010560544
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown