MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL GUIDE HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71674001
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery for a intertrochanteric hip fracture, intramedullary nailing, when drilling for the distal screw through the 4.0/9.0 drill sleeve and 125d drop, the 4.0mm drill bit could not hit its target hole.Rather than target the hole, the above instrumentation caused the drill bit to target into the metal of the nail.The guide bolt holding the intertan short nail seemed to be secure.It had to remove the drill guide and finish the surgery by freehand locking the distal screw.It is very likely that some sort of defect/wear on the instruments is causing misalignment.The procedure was resumed, after a significant delay, with a change in the surgical technique.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference: case(b)(4).
Additional Manufacturer Narrative
H3, h6: the associated devices were returned and evaluated.A visual inspection of the returned drill guide reveals the threads are stripped and the connecting holes have gouges.The two intertan drops reveal scratches, burrs, gouges and the pull pins are loose.The bolt reveals the threads are stripped.For the guide bolt, a review of complaint history revealed similar events 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.For the other devices, 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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.These devices are reusable instruments that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: DRILL GUIDE HANDLE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 16570458
• Report Number: 1020279-2023-00584
• Device Sequence Number: 4748295
• Product Code: HSB
• UDI-Device Identifier: 03596010560469
• UDI-Public: 03596010560469
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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 Model Number: 71674001
• Device Catalogue Number: 71674001
• Device Lot Number: 17ACL0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 03/19/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 71674002/125 RAD DRILL GDE DROP; 71674003/130 RAD DRILL GDE DROP; 71674071/7/16 GUIDE BOLT
• Patient Age: 86 YR
• Patient Sex: Male