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

Model Number 71674068

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2020

Event Type  malfunction  

Event Description

It was reported that the subtroc lag screw driver broke outside the patient, during a trauma surgery.No broken pieces fell inside the patient's wound.The procedure was finished using a smith and nephew back up device, with no surgical delay and no injury to the patient.

Manufacturer Narrative

Additional information received by the customer has identified that this event has been already reported under 1020279-2020-04814.The new information confirms that this is a duplicate complaint, therefore, if further details are provided in future confirming the opposite, our files will be updated accordingly and a further report will be submitted outlining both events details and our investigations performed.

Manufacturer Narrative

Supplemental mdr 1 was a mistake.It is not a duplicate.The device, used in treatment, was returned for evaluation.A visual inspection of the returned lag screw driver shaft confirms a piece of the tip is broken off.The broken piece was not returned with the device.This piece was not returned with the device.The device exhibits signs of significant wear and usage.This device was manufactured in 2016.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: SUBTROC LAG SCREW DRIVER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10588648
• MDR Text Key: 208621483
• Report Number: 1020279-2020-04869
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010560612
• UDI-Public: 03596010560612
• 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,Followup
• Report Date: 10/08/2020

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: 71674068
• Device Catalogue Number: 71674068
• Device Lot Number: 16LSP0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 10/05/2020; 10/05/2020
• Supplement Dates FDA Received: 10/08/2020; 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1