MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 85/80; NAIL, FIXATION, BONE

Model Number	71677085
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after surgery the surgeon found a shadow in a x-ray image.After reconfirming the image, he found something remained.Then the same surgery was performed again using other implants/devices.After pulling out the nail previously implanted, a metallic piece was removed from the medullary space.Then removing the metal materials as much as possible, the surgery was completed by implanting other nail.Back-ups available.Delay greater than 30 min.
Additional Manufacturer Narrative
The devices, used in treatment were returned for evaluation.A clinical evaluation was conducted and confirms based on the lab retrieval analysis, the metal debris was most likely due to the stripping off of the screw threads along with intertan damage secondary to encountered resistance during implantation through the proximal screw hole.Based on the report of surgeon removed ¿the metal materials as much as possible¿ from the medullary space, the possibility of retained foreign bodies could not be entirely ruled out.The patient impact beyond imaging, nail explantation/revision and reported 4.5 hour surgical delay could not be determined with confidence as the patient status was reportedly unknown.No further medical assessment can be rendered at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.Factors and/or some potential probable causes that could contribute to the reported event include but not limited to design of device, improper size device used, lifetime of device, material in use, overuse, procedural/user error, traumatic injury, unclear user instructions.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.

• Brand Name: LAG/COMP SCREW KIT 85/80
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9281433
• Report Number: 1020279-2019-03888
• Device Sequence Number: 16711583
• Product Code: JDS
• UDI-Device Identifier: 03596010563293
• UDI-Public: 03596010563293
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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
• Operator of Device: Health Professional
• Device Model Number: 71677085
• Device Catalogue Number: 71677085
• Device Lot Number: 19ET21618
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention