MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN LAG/COMP KIT 85/80; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71642685

Device Problems Material Separation (1562); Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2020

Event Type  Injury  

Event Description

It was reported that, during treatment of a femoral shaft fracture with meta-tan, the lag screwdriver could not keep/capture the lag screw while inserting: it appears that the threaded part of retaing rod broken off and the piece stayed inside of the mating part of the lag screw.It is possible that some metallic debris have fallen in the operative field.After retrieving the lag screw, the outer shaft of the lag screwdriver was used to insert another lag screw.The case was delayed for 1 hour.The patient outcome is unknown.

Manufacturer Narrative

The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.The tip of the threads on the retaining rod fractured off inside the lag screw.All pieces were returned.The slotted end of the retaining rod is also heavily damaged.The driver was manufactured in 2016 and shows signs of extensive usage.The lag screw and compression screws were manufactured in 2017 and show signs of use.The medical investigation concluded that based on the report of the lag screw size change, procedural vs user event cannot be ruled out as a likely cause.The metallic debris from the thread of the retaining rod is made of ti-6al- 4v, which is intended for surgical applications and is biologically compatible.There is potential risk for local irritation/discomfort and/or migration if debris from the retaining rod breakage was retained in the operative field.The patient impact beyond the surgical time extension cannot be determined.No further clinical/medical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 driver is a reusable instrument that can be exposed to numerous surgeries.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.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: META-TAN LAG/COMP KIT 85/80
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 10041550
• MDR Text Key: 190471394
• Report Number: 1020279-2020-01535
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K092748
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71642685
• Device Lot Number: 17MT96336
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention