MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 24CM 130D; NAIL, FIXATION, BONE

Model Number	71934480
Medical Device Problem Codes	Break (1069); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a trauma surgery, an intertan 10mm x 24cm 130d broke inside the patient.Therefore a revision surgery was performed to remove the broken device.During revision surgery was also explanted a lag screw, a compression screw and 5.0 trigen lp screw.Patient was already released from the hospital.Patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the fracture confirmed.The clinical/medical investigation concluded that, although the two photos provided supports the reported failure, without the requested clinical information, the root cause of the reported breakage cannot be determined.Per subsequent e-mail, the patient underwent a revision and all the broken pieces were recovered.Based on the information provided, the patient was discharge from the hospital, however, the patient¿s condition is unknown.Therefore, the impact to the patient beyond that which has already been reported cannot be determined.Should and additional relevant clinical information be provided, this complaint will be re-assessed.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.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, abnormal loading of limb or excessive forces applied to implant.Based on this investigation, the need for corrective action is not indicated.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: INTERTAN 10MM X 24CM 130D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11907714
• Report Number: 1020279-2021-04828
• Device Sequence Number: 19955991
• Product Code: JDS
• UDI-Device Identifier: 00885556105146
• UDI-Public: 00885556105146
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71934480
• Device Catalogue Number: 71934480
• Device Lot Number: 20GM18269
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 05/31/2021
• Supplement Report FDA Received Date: 08/16/2021
• 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; Required Intervention