MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 65MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645065
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during follow up after an internal fixation procedure, it was evident that a trigen low profile screw 5.0mm x 65mm was loose and outside the nail.The screw was removed from the hind foot nail and the system was left in this way pending the consolidation of the fracture.Patient's current health status is unknown.
Additional Manufacturer Narrative
G3, h2, h3, and h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the responses to clinical requests were not provided.Therefore, s+n has not received the adequate documentation to fully evaluate the root cause of the reported failure.Based on the information provided, the screw was removed from the hind foot nail and the system was left in the way it was pending the consolidation of the fracture.Since it was reported the patient¿s health status is unknown.The impact to the patient beyond that which has already been reported cannot be determined.Should any additional relevant clinical information be provided, this complaint will be re-assessed.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 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.Some potential probable causes for this event could include a fit/sizing issue or poor insertion technique.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.We consider this investigation closed.
Additional Manufacturer Narrative
Section: h3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device shows signs of extensive use.The clinical/medical evaluation concluded that the responses to clinical requests were not provided.Therefore, s+n has not received the adequate documentation to fully evaluate the root cause of the reported failure.Based on the information provided, the screw was removed from the hind foot nail and the system was left in the way it was pending the consolidation of the fracture.Since it was reported the patient¿s health status is unknown.The impact to the patient beyond that which has already been reported cannot be determined.Should any additional relevant clinical 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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 65MM
• 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: 12130119
• Report Number: 1020279-2021-05786
• Device Sequence Number: 3427505
• Product Code: HSB
• UDI-Device Identifier: 00885556216293
• UDI-Public: 00885556216293
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K161264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2021

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: 71645065
• Device Catalogue Number: 71645065
• Device Lot Number: 20GM16983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 08/17/2021; 11/17/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/19/2021; 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2020
• 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: Female