MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 24CM 125D; NAIL, FIXATION, BONE

Model Number	71934479
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a primary surgery, one intertan 10mm x 24cm 125d broke.After that, a revision surgery was performed to remove the broken nail and replace it.No health consequences were reported.
Additional Manufacturer Narrative
The device, used in treatment, was not received for evaluation.However, the pictures were reviewed, and the breakage was confirmed.The shipping information was provided and all efforts were made to locate the device but we have no evidence that it was ever received by the complaint investigation team for evaluation.The clinical/medical investigation concluded that, the x-ray photos provided support and confirm the report.Based on the information provided the root cause of the reported intertan breakage is due to nonunion of the previous fracture site.There is no report of the patient¿s current condition following the revision.However, it is likely the patient will experience pain and possibly have post op rehab.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.A review of complaint history did not reveal additional complaints for the listed batch.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 nonunion of the previous fracture site, a traumatic injury or surgical technique.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.H10.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the breakage was confirmed.The clinical/medical investigation concluded that, the x-ray photos provided support and confirm the report.Based on the information provided the root cause of the reported intertan breakage is due to nonunion of the previous fracture site.There is no report of the patient¿s current condition following the revision.However, it is likely the patient will experience pain and possibly have post op rehab.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.A review of complaint history did not reveal additional complaints for the listed batch.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 nonunion of the previous fracture site, a traumatic injury or surgical technique.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 125D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12319250
• Report Number: 1020279-2021-06354
• Device Sequence Number: 14496460
• Product Code: JDS
• UDI-Device Identifier: 00885556105092
• UDI-Public: 00885556105092
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71934479
• Device Catalogue Number: 71934479
• Device Lot Number: 19AM19339
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 10/01/2021; 10/14/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 10/04/2021; 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; Required Intervention