MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN LAG/COMP KIT 90/85; INSTRUMENT, BENDING OR CONTOURING

Model Number	71642690
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a planned surgery of meta-tan removal, it was difficult to remove the meta-tan nail with an unknown meta-tan lag screw driver ((b)(4)).Therefore, meta-tan lag screw driver was changed to easy out small.The nail was removed, but part of an unknown lag screw ((b)(4)) and the easy out small ((b)(4)) broke inside the patient.All pieces were removed.The procedure was completed with a less than 30 mins delay using the same device.No other complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the failure mode was confirmed.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 complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is 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 90/85
• Common Device Name: INSTRUMENT, BENDING OR CONTOURING
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11696358
• Report Number: 1020279-2021-03259
• Device Sequence Number: 3073202
• Product Code: HXP
• UDI-Device Identifier: 00885556132975
• UDI-Public: 00885556132975
• 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): 08/24/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71642690
• Device Catalogue Number: 71642690
• Device Lot Number: 17LT96108
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 08/24/2021
• 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: Hospitalization; Other; Required Intervention