MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN LAG/COMP KIT 105/100; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71642605
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a intramedullary surgery on (b)(6) 2021, a revision surgery was made on (b)(6) 2021 because an incorrect metatan intergrated lag was screwed into the intertan construct (boxes between intertan & metatan lag screws are almost identical to look at).Current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, no relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.We are currently unable to rule out human error as a contributing factor to the reported events.Should any additional clinical information be provided this complaint will be re-evaluated.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the label specification for meta-tan and for intertan was conducted and it revealed the information regarding the product, such as part number, name, and size, was found to be clear, legible, and complete in both labels.A review of the risk management files revealed that this failure mode and associated harm has been identified and the anticipated risk level is still adequate.The product meets the specifications at the time of manufacture.Possible causes could include but not limited to user 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 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 105/100
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12216949
• Report Number: 1020279-2021-06038
• Device Sequence Number: 4600371
• Product Code: HSB
• UDI-Device Identifier: 00885556133071
• UDI-Public: 00885556133071
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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 Expiration Date: 02/02/2025
• Device Model Number: 71642605
• Device Catalogue Number: 71642605
• Device Lot Number: 15BT50689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown