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

Model Number 71645065

Device Problem Difficult to Insert (1316)

Patient Problem Rupture (2208)

Event Date 03/10/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

It was reported that, during an internal fixation surgery, a trigen low profile screw 5.0mm x 65mm became hard to turn just before the screw hole.Then a noise was heard, and the screw could not be inserted.So, it was removed and drilling was performed again, but the same issue occurred.After this, the surgeon gave up screw insertion; and the procedure was finished with a five minute delay, without a back up.It was confirmed that all the instruments had been aligning correctly in order to insert the original screw into the intended position.An additional screw was placed at another position to compensate for this issue.Patient's current health status is unknown, but it was reported that bone quality was normal.

Manufacturer Narrative

B5: event description.

Event Description

It was reported that, during an internal fixation surgery, a trigen low profile screw 5.0mm x 65mm became hard to turn just before the screw hole.Then a noise was heard, and the screw could not be inserted.So, it was removed and drilling was performed again, but the same issue occurred.After this, the surgeon gave up screw insertion; and the procedure was finished with a five minute delay, without a back up.It was confirmed that all the instruments had been aligning correctly in order to insert the original screw into the intended position.Patient's current health status is unknown, but it was reported that bone quality was normal.

Manufacturer Narrative

H3, h6: the nail was not returned but the screw was returned and evaluated.The visual inspection of the screw does not reveal any defects.The clinical/medical investigation concluded that, per complaint details, the surgeon was unable to insert a trigen low profile screw during an internal fixation procedure.Based on the information provided, the procedure was completed with a 5 minute delay without a back-up device.As of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient's current condition is unknown and the patient impact beyond the revision surgery could not be determined.No further clinical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the instructions for use documents for intramedullary nail system revealed that a correct surgical technique is essential to a successful outcome.Proper reduction of fractures and proper placement of implants are necessary to effectively treat patients using metallic surgical implants.Also, a proper type and size of implant must be selected to insure effective treatment of patients, this has been identified as preoperative planning.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According to the drawing print, the device size should be 5.0mm x 65mm.Besides, according to the inspection drawing of the screw, final inspection includes the verification of part configuration per print and parts are free of burrs or sharp edges.According to work instructions of the nail, the holes should be verified.A review made by the quality engineering team revealed that upon inspection of the defective part, it was discovered that the hex size was found to be undersized.To investigate further, a thorough review of the manufacturing records was conducted, which did not indicate any manufacturing issues or anomalies related to this specific batch.At this time, we do have reason to suspect that the product failed to meet specifications at the time of manufacture.The root cause of this event was determined to be manufacturing process errors such as: off-set error, set-up pc and wear or broken tool.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 65MM
• Type of Device: 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: 16668658
• MDR Text Key: 312584983
• Report Number: 1020279-2023-00751
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556216293
• UDI-Public: 00885556216293
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71645065
• Device Catalogue Number: 71645065
• Device Lot Number: 22EM06360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male