MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 80MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, after the meta-tan nail was inserted and screws placed in femoral mode, the 80mm trigen screw that runs from greater to lesser trochanter broke.No delay to procedure or injury to the patient.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.A clinical evaluation was conducted and concluded that, without product return for evaluation and/or clinically relevant supporting documentation, a thorough medical investigation could not be performed.Reportedly, a trigen screw broke during a meta-tan procedure; however, no surgical delay or injury to the patient was reported.The root cause of the event could not be concluded.No further patient impact is anticipated.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no 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 was previously identified.Some potential probable causes for this event could include incorrect indications or a procedural error.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 80MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9690990
• Report Number: 1020279-2020-00508
• Device Sequence Number: 19548207
• Product Code: HSB
• UDI-Device Identifier: 00885556216590
• UDI-Public: 00885556216590
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

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: 08/02/2025
• Device Model Number: 71645080
• Device Catalogue Number: 71645080
• Device Lot Number: 15HM02487
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR