MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 25MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645025
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during intertan trauma surgery, it was found that the trigen low profile screw 5.0mm x 25mm (case: (b)(4)) and the long hexdriver (case: (b)(4)) mated incorrectly.The surgery was completed with a less than 30 mins delay using other smith and nephew back-up screw.No other complications were reported.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device shows signs of damage from attempted use.The part shows significant damage at entrance of the hex and can not confirm the if the hex drive feature is conforming prior to attempting to use it.Work-order is also 100% visually checked for parts configuration to print.A review of the dhr performed and did not indicate any issues.However, the implemented controls and detection points are adequate to capture this type of defect and is not considered a systemic issue per history of complaints and non-conformances.Possible causes of the defect are: wore and broken tool and machine variance.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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 25MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11683496
• Report Number: 1020279-2021-03067
• Device Sequence Number: 16925932
• Product Code: HSB
• UDI-Device Identifier: 00885556215494
• UDI-Public: 00885556215494
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71645025
• Device Catalogue Number: 71645025
• Device Lot Number: 19FM09395
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 04/18/2021
• Supplement Report FDA Received Date: 09/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1