MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 18CM 130D; NAIL, FIXATION, BONE

Model Number	71675384
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that primary sugery was performed on (b)(6) 2019.Patient suffered a pseudoarthrosis and nail had to be removed.During the removal of the device, the physician realized the nail was broken.The device and all the pieces were removed from the patient and another intertan nail with a different sizes was placed.The procedure was being performed was the right hip osteosynthesis.The patient is stable without any damage since all the pieces were removed.Another of the same device was used in order to complete the procedure.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.A visual inspection of the device could not be performed.A relationship between the device and the reported event could not be corroborated.There is no information to suggest the device failed to meet specifications.A clinical evaluation was conducted and no relevant clinical medical information was provided to conduct a thorough medical assessment.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Some potential probable causes could include improper device selection or support.Please refer to the instructions for use for recommendations on proper use of the device to prevent future reoccurrence of the reported event.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: INTERTAN 10S 10MM X 18CM 130D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9284405
• Report Number: 1020279-2019-03915
• Device Sequence Number: 2363476
• Product Code: JDS
• UDI-Device Identifier: 00885556105740
• UDI-Public: 00885556105740
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 01/04/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71675384
• Device Catalogue Number: 71675384
• Device Lot Number: 17EM15619
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 01/16/2020; 12/31/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 01/20/2020; 01/04/2021
• 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: Required Intervention