MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 11.5MM X 34CM; NAIL, FIXATION, BONE

Model Number	71655234
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a trauma surgery a meta-nail tibial 11.5mm x 34cm was introduced with no issues.When reaching the fracture, the physician started to rotate the nail by the piece that carries the nail and, suddenly, the piece broke.Then, by using a hook and through the holes of the nail it could be removed from the patient.The procedure was successfully completed with a delay of greater than 30 minutes using a smith and nephew back up device.The patient is stable and no other complications were reported.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The manufacturing process of the device did not contribute to the reported event.The lab analysis concluded that based on this investigation, it was concluded that the meta-nail tibial 11.5mm x 34cm nail fractured by the initiation and subsequent propagation of shear forces.The shear forces eventually propagated to an extent that the remaining cross section could not bear the imposed loading, which led to an overload fracture.No material or manufacturing deviations were observed during this investigation.A review of complaint history did not reveal similar events for the listed device.The clinical/medical evaluation concluded that photos were provided for review via e-mail and confirm the reported breakage.Per report, the broken piece was retrieved from the patient and the procedure was completed using a backup device.It was also communicated that the patient was under spinal anesthesia was not general anesthesia or sedation.The patient¿s condition was reported as stable.Since no further harm is anticipated no further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have 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 document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file, include but not limited to excessive forces applied to implant and inadequate design.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: META-NAIL TIBIAL 11.5MM X 34CM
• Common Device Name: NAIL, FIXATION, BONE
• 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: 11773657
• Report Number: 1020279-2021-03735
• Device Sequence Number: 3778653
• Product Code: JDS
• UDI-Device Identifier: 03596010585653
• UDI-Public: 03596010585653
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K061019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71655234
• Device Catalogue Number: 71655234
• Device Lot Number: 17GM13398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female