MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 38CM 130D RIGHT; NAIL, FIXATION, BONE

Model Number	71675536
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during intertan surgery, the set screw was advanced to where the lag screw reamer would not pass through the implant.A delay of less than 30 minutes occurred due to this event.A backup device from smith and nephew was used to complete the procedure.The outcome of the patient is unknown.No additional details were provided at this time.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms the images provided confirm the report.Based on the limited information provided and without the return of the device the clinical root cause of the reported events could not be determined.Assembly issue vs user technique cannot be ruled out.Per case details, the procedure was completed using a back-up device.The impact to the patient beyond the reported cannot be concluded.Should additional information become available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of complaint history for the listed part revealed no prior 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 risk management files and instructions for use found that the reported failure was documented appropriately.Possible causes could include but not limited to surgical technique used, size of device or user/procedural error.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, 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.We consider this investigation closed.

• Brand Name: INTERTAN 10S 10MM X 38CM 130D RIGHT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11449972
• Report Number: 1020279-2021-01946
• Device Sequence Number: 11641134
• Product Code: JDS
• UDI-Device Identifier: 00885556345498
• UDI-Public: 00885556345498
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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: 71675536
• Device Catalogue Number: 71675536
• Device Lot Number: 21AM03163
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 05/04/2021
• 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: Hospitalization; Other; Required Intervention