MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 11.5MM X 44CM LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71649744
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Limb Fracture (4518)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
"it was reported that, 8 months after a procedure had been performed with trigen traptan 11.5mm x 44cm left to treat a simple long bone fracture in the proximal region of the femur, the patient experienced pain around the greater trochanter.The trigen traptan 11.5mm x 44cm left was explanted, but there is no confirmation if another nail was used in exchange.After 5 months from the nail's explantation, a subsequent union of the fracture was reported as a general outcome.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known and it is not possible to collect it.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known and it is not possible to collect it.Without adequate materials to fully evaluate the complaint, a thorough medical assessment cannot be performed.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of complaint history did not reveal additional complaints for the listed device for the same failure mode.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.Additional information: d3.

• Brand Name: META-TAN 11.5MM X 44CM LEFT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12512553
• Report Number: 1020279-2021-07058
• Device Sequence Number: 3908320
• Product Code: HSB
• UDI-Device Identifier: 00885556340998
• UDI-Public: 00885556340998
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K092748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: 71649744
• Device Catalogue Number: 71649744
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/15/2021
• 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; Other