MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG DRIVER RETAINING ROD ASSY; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71674087

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/01/2020

Event Type  Injury  

Event Description

It was reported that, during trauma surgery, while removing the lag driver retaining rod assembly from lag screw after seating the screw, the surgeon pulled the lag driver retaining rod assy.The lag driver retaining rod assembly was still connected to the lag screw, and then the tip of the lag driver retaining rod assembly broke inside the patient's body.The piece was not removed and remains inside the patient.There is no plan to remove the tip from patient at this moment.The procedure was finished with no surgical delay.

Manufacturer Narrative

The device, used in treatment was not fully returned instead the broken part still remains inside the patient.Visual inspection of the returned device confirms that the device is cracked and damaged and has signs of wear and tear from use.The device was manufactured in 2011.According to clinical medical investigation , the broken piece was not retrieved from the patient.No clinically relevant supporting documentation was provided for inclusion in a medical investigation.Based on the limited information provided, the root cause of the reported breakage could not be determined but procedural error cannot ruled out.The device is not approved for implantation; therefore, long-term implantation data is not available.The patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of possibly retained non-implantable foreign body fragments cannot be determined.Per report no plans have been made to remove the broken tip.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.

• Brand Name: LAG DRIVER RETAINING ROD ASSY
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10292502
• MDR Text Key: 199439727
• Report Number: 1020279-2020-03310
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010580443
• UDI-Public: 03596010580443
• 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: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71674087
• Device Catalogue Number: 71674087
• Device Lot Number: 11FSP0011
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other