MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 38CM 125D RIGHT; NAIL, FIXATION, BONE

Model Number	71675535
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, while device was inside the patient, it was noticed that the incorrect item came in the box.The box was labeled with part number 71675535 when actually what was in the box was a device with part number 71675532.The correct device was located and used to complete the procedure.Surgery was not delayed more than 30 min.The patient was not harmed.
Additional Manufacturer Narrative
Additional information: b3 / b4 / b5 / b6.
Event or Problem Description
It was reported that during surgery, while device was inside the patient, it was noticed that an incorrect item was in the box.Box was labeled with part number 71675535 when actually what was in the box was a device with part number 71675532.This was noticed was one the device was implanted and several extra oles were drilled in the patients femoral neck due to the device.Correct device was located and used to complete the procedure.No injury and a delay of less than 30 minutes was reported.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The package labeling does not match the device that was returned.Package labeling is for device 71675535 batch 20cm25278.Device returned is 71675532 batch 20dm01466.The device was manufactured in 2020.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.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The potential probable cause for this event is likely a manufacturing process error.Based on this investigation, the need for corrective action is indicated.Should 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.Case-2020-00006776-1.
Additional Manufacturer Narrative
Section h3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The package labeling does not match the device that was returned.Package labeling is for device 71675535 batch 20cm25278.Device returned is 71675532 batch 20dm01466.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 reason to suspect that the product failed to meet product specifications at the time of manufacture.The potential probable cause for this event is likely a manufacturing process error caused by inadequate line clearance when producing more than one batch.Based on this investigation, the need for corrective action is indicated.As a result of the investigation, several process improvements were implemented related to training, process monitoring and in process inspection.In addition, this event was addressed through a market removal of the product.Containment and remedial actions were performed for the impacted finished product.Should the 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.H6: health effect - clinical code, medical device problem code and component code.

• Brand Name: INTERTAN 10S 10MM X 38CM 125D RIGHT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks rd.; memphis, TN 38116 ; 0447940038246
• MDR Report Key: 10230373
• Report Number: 1020279-2020-02903
• Device Sequence Number: 14238620
• Product Code: JDS
• UDI-Device Identifier: 00885556345443
• UDI-Public: 00885556345443
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/28/2022

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: 71675535
• Device Catalogue Number: 71675535
• Device Lot Number: 20CM25278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 06/15/2020; 02/24/2021; 09/27/2022
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 07/31/2020; 02/25/2021; 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0772-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown