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	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an internal fixation surgery, performed on (b)(6) 2021, screws of meta-tan lag/comp kit 100/95 ((b)(4)) were used through an intertan 11.5mm x 20cm 125d ((b)(4)), leading to early implant failure.With some further investigation, it was discovered that there was no sales rep present at the original operation, and the error was made by a junior clinician at point of surgery.The surgeon and hospital do not blame the implants at all, and the metatan screws have now been more clearly labelled for future reference.This issue was resolved with a revision performed on (b)(6) 2021.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint details, this represents a procedure complication and does not represent a device malfunction.Based on the information provided, the error was made by a junior clinician at point of surgery.According to the report, the metatan screws have now been clearly labelled, the surgeon does not blame the implants and the issue was resolved with a revision.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this complaint will be re-assessed.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 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 products failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural variance or user error.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices 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.

• 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: 12105181
• Report Number: 1020279-2021-05620
• Device Sequence Number: 17087504
• Product Code: HSB
• UDI-Device Identifier: 00885556133088
• UDI-Public: 00885556133088
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K092748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: 17HT90964
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/19/2021
• 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; Required Intervention