MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 40MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645040
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the head of the trigen low profile screw 5.0mm x 40mm did not mate to the driver.S&n back up device was available to complete the procedure.No injury to patient.There was 10 minutes delay.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is missing the hex feature in the head, rendering the device inoperable.A review of complaint history did not reveal additional complaints for the listed batch.An additional product evaluation was performed by the manufacturing group which determined that no further investigation is require due to no additional complaints were identified for this defect or batch.Additionally, 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.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The potential probable causes for this event could include but not limited to a user or procedural error.At this time, we have reason to suspect that the product failed to meet 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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 40MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10756012
• Report Number: 1020279-2020-05930
• Device Sequence Number: 19747162
• Product Code: HSB
• UDI-Device Identifier: 00885556215791
• UDI-Public: 00885556215791
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 71645040
• Device Catalogue Number: 71645040
• Device Lot Number: 20BM25552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1