MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 9MM X 40CM RIGHT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71640540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, 10 months after a procedure had been performed with trigen traptan 9 mm x 40 cm right to treat a simple long bone fracture in the midshaft region of the femur, the patient's outcome was not successful, as the fracture was not completely reduced.A revision surgery was performed to treat this adverse event.The trigen traptan 9 mm x 40 cm right was explanted and exchanged with an unspecified nail, with the subsequent union of the fracture.It is unknown how much time took to achieve the reported final 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
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the data presented in this article was noticed in a retrospective post-market clinical follow up activity (pmcf) that reported, ¿ten months post procedure with trigen traptan 9mm x 40cm right for the treatment of a simple long bone fracture in the midshaft region of the femur, the patient's outcome was not successful, as the fracture was not completely reduced resulting in a revision.Per the complaint, the device was explanted and exchanged with an unspecified nail, with the subsequent union of the fracture.¿ however, without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.No further medical assessment is warranted at this time.Should any additional medically relevant supporting documentation be provided, this complaint would be re-assessed.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.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.Factors and/or potential causes that could contribute to the reported event include procedural variance, surgical technique, healing issues and/or user error.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.
Additional Manufacturer Narrative
H6 and results of investigation: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, the data presented in this article was noticed in a retrospective post-market clinical follow up activity (pmcf) that reported, ¿ten months post procedure with trigen traptan 9mm x 40cm right for the treatment of a simple long bone fracture in the midshaft region of the femur, the patient's outcome was not successful, as the fracture was not completely reduced resulting in a revision.Per the complaint, the device was explanted and exchanged with an unspecified nail, with the subsequent union of the fracture.¿ however, without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.No further medical assessment is warranted at this time.Should any additional medically relevant supporting documentation be provided, this complaint would be re-assessed.A review of complaint history did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, procedural/user error, surgical/post operative complications, healing issues and/or patient condition.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.We consider this investigation closed.

• Brand Name: META-TAN 9MM X 40CM RIGHT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12512581
• Report Number: 1020279-2021-07059
• Device Sequence Number: 3908321
• Product Code: HSB
• UDI-Device Identifier: 00885556339244
• UDI-Public: 00885556339244
• 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: Foreign,Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2022

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: 71640540
• Device Catalogue Number: 71640540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 10/29/2021; 01/20/2022
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 11/01/2021; 01/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown