MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 18CM 125D; NAIL, FIXATION, BONE

Catalog Number	71675202
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, after they performed the reduction of the fracture, step by step in order to do the preparation of the spinal canal, an intertan nail 11.5x18cm 125 ° was passed to the table and this was implanted in the patient, the respective steps were followed for placement the kit screws that go to the femoral head.System was blocked with the respective piece to slide the locking bolt but in x-rays it was evidenced that it did not block, due to this the kit screws and the nail were removed and a new nail was necessary because there was no other nail in the institution or at the time.By decision of the specialist, a nail 10sx18cm 125° was placed that is, a smaller diameter than the one previously decided to be placed.This was previously verified before implanting it in the patient, evidencing the presence of the locking bolt, the nail was passed into the patient and the respective steps were again carried out for the placement of the screws and the locking of the system.The 11.5x18cm 125 ° intertan nail was checked on the surgical table and it was evident that the locking bolt was not found.No delay was reported.
Additional Manufacturer Narrative
The associated complaint device was not returned.The medical investigation concluded that, based on the information provided, the initial report of the ¿system block¿ was possibly due to user error as it was reported that ¿in x-rays it was evidenced that it did not block¿.The risk to the patient comes in using a nail that had a smaller diameter than what was planned and putting a smaller nail in after removal of the slightly larger nail and this may lead to less than ideal fracture fixation.It was not reported that the locking bolt remained within the patient.The procedure was completed with no significant delay or patient injuries.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: INTERTAN 11.5MM X 18CM 125D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9131482
• Report Number: 1020279-2019-03493
• Device Sequence Number: 16640425
• Product Code: JDS
• UDI-Device Identifier: 03596010561053
• UDI-Public: 03596010561053
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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 Catalogue Number: 71675202
• Device Lot Number: 19DM19734
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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