MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 27.5MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645027
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient had an intertan surgery.After the surgery surgeon found out there was fracture around distal screws, he thinks the diameter of the part under the screw head is wide and the diameter of drill is not fit for it.
Additional Manufacturer Narrative
The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms the images provided confirm the reported.Based on the limited information provided the root cause of the fracture could not be determined and no conclusion can be made on if the use of longer screws can prevent the fracture.The impact to the patient beyond the reported issue cannot be concluded.Should additional information becomes available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches 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.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.At this time, we have no 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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 27.5MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9938481
• Report Number: 1020279-2020-01234
• Device Sequence Number: 654680
• Product Code: HSB
• UDI-Device Identifier: 00885556215548
• UDI-Public: 00885556215548
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71645027
• Device Catalogue Number: 71645027
• Device Lot Number: 18FT05482
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/17/2020
• 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: Hospitalization; Required Intervention