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 Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2020

Event Type  malfunction  

Event Description

It was reported that, during surgery, the lag screw drill sleeve did not easily slide into the 125 rad drill gde drop.This happened during use outside the patient; by hitting with a hammer, the sleeve attached to the drop.The procedure was completed with this device.10 minutes delay.No injury to patient.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.Per the photo attached to the complaint, it confirms the locking pin is damaged causing the stated failure.A medical investigation was conducted and confirms per subsequent e-mail no relevant clinical information nor the device will be provided for inclusion in his medical investigation.Therefore, the root cause of the reported failure cannot be determined.It was reported this event happened during outside of the patient and by hitting using a hammer, the sleeve attached to the drop.Per communications, the same device was used to completed with a delay of 10 minutes.Since there was no injury reported to the patient, no further clinical/medical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints 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 the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes 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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further investigation warranted for these complaints; 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: 10738284
• MDR Text Key: 213153280
• Report Number: 1020279-2020-05779
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/14/2021

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
• Device Operator: Health Professional
• Device Model Number: 71674002
• Device Catalogue Number: 71674002
• Device Lot Number: 12CM03678
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 02/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1