MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN LAG/COMP KIT 100/95; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71642600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a planned surgery for nail removal, the threaded part of the devices deformed/broke.The tips from the devices do not remain in the patient's body, however the slotted part of the lag screw also broke off and the pieces remain inside the patient body.It was attempted to removed the pieces using an easy out but it did not mate to the lag screw.The procedure was concluded without removing the nail and lag screw.The pieces from lag screw remains.A 60 min delay was reported.Patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A medical investigation was conducted and confirms the single photo confirms the stated failure.Based on the product evaluation, aged related wear was the likely cause of reported breakage.However, we cannot rule out a procedural event vs user error as a contributing factor.The lag screw and the nail are both implantable and we cannot rule out the possibility of mri restrictions, local irritation, migration or micromotion of the retained pieces.Since, the reported sixty- minute delay did not result in harm to the patient.No further clinical/medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.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 risk management files and instructions for use found that the reported failure was documented appropriately.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.The potential probable cause for this event is likely a procedural error.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.We consider this investigation closed.

• Brand Name: META-TAN LAG/COMP KIT 100/95
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10376753
• Report Number: 1020279-2020-03762
• Device Sequence Number: 19613046
• Product Code: HSB
• UDI-Device Identifier: 00885556133088
• UDI-Public: 00885556133088
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71642600
• Device Catalogue Number: 71642600
• Device Lot Number: 18BT99242
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 09/02/2021
• 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: Required Intervention