MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 125 RAD DRILL GDE DROP; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71674002

Device Problem Connection Problem (2900)

Patient Problem No Code Available (3191)

Event Date 09/05/2020

Event Type  Injury  

Event Description

It was reported that during surgery while the instrument was outside the patient, the intertan distal screw targeting setup failed causing surgeon to drill into nail., surgeon free handedly reset the drill and the procedure was completed with the same nail, and it does not affect the surgical technique.Delay reported of less or equal than 30 minutes.

Manufacturer Narrative

The device, used treatment, was returned for evaluation.A visual inspection does not find any obvious signs of damage to the device.There is no signs of wear or use as well.The device was manufactured in 2020.A functional evaluation was conducted and failure mode is confirmed for the returned part.The plunger assembly was installed at a slight angle which would cause the drill guide sleeve to not line up properly to allow the plunger to engage with the drill guide sleeve in order to lock it into place.When comparing to inventory / parts in stock the discrepant part is visibly assembled off-center.A medical investigation was conducted and this complaint from the united states reports the targeting setup failed causing surgeon to drill into nail.Reportedly, the surgeon free handedly reset the drill and the procedure was completed with the same nail, and it does not affect the surgical technique.A delay was reported of less than or equal to 30 minutes.To other complication was reported.No harm or impact to the patient.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of complaint history on the listed part revealed no prior complaint for the listed batch with the same failure mode.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 risk management files found that the reported failure was documented appropriately.The device exhibits signs of significant use and wear.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 125 RAD DRILL GDE DROP
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10618440
• MDR Text Key: 209535940
• Report Number: 1020279-2020-05074
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010570970
• UDI-Public: 03596010570970
• Combination Product (y/n): N
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

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 Operator: Health Professional
• Device Model Number: 71674002
• Device Catalogue Number: 71674002
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 09/05/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention