MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ADOLESCENT TAN 8.5X40L; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71645140
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a trauma surgery while placing the final nail after the second impact, the proximal tabs of the nail were opened and broken, the nail was inside the patient.With manual movements and a lot of caution, the doctor removed the nail from the patient.Procedure was completed with a new implant and no injury was reported.Delay was above 30 minutes due to the removal of the nail and the new implantation.
Additional Manufacturer Narrative
The affected legion ps xlpe high flexion insert was returned and evaluated.Our investigation included a lab analysis which indicated the nail fracture occurred proximally.The bone cement was applied to the entire length of the nail except the proximal end.The cement thickness was widely varied from proximal to the distal end.The fractured proximal keys were not returned.Based on the analysis conducted, the exact cause of the reported failure was not able to be determined.A clinical evaluation noted there is no clinical relevant documentation provided to perform a thorough medical investigation.No further medical assessment is warranted at this time.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the part revealed no prior complaints for the listed batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: ADOLESCENT TAN 8.5X40L
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7349010
• Report Number: 1020279-2018-00327
• Device Sequence Number: 19155429
• Product Code: HSB
• UDI-Device Identifier: 03596010541352
• UDI-Public: 03596010541352
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K040929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2018

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 Expiration Date: 09/28/2018
• Device Catalogue Number: 71645140
• Device Lot Number: 08JT23835
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 07/05/2018
• 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: Other
• Patient Age: 43 YR
• Patient Weight: 70