MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 34CM 130D RIGHT; NAIL, FIXATION, BONE

Model Number	71675532
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before the procedure during the inspection, a 130-degree nail was needed, but when the package was opened a 125-degree nail was coming, so the available backup was used to complete the procedure.The procedure was completed without delay.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The associated device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This issue was previously identified and is being evaluated through our internal quality hold process.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.Based on this investigation, the need for corrective action is indicated.Without the return of the actual product involved, our investigation could not proceed.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.
Additional Manufacturer Narrative
H10: the device was not returned for evaluation, however the reported event could be confirmed since the batch number is part of a market removal action.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.However, a review made by the quality engineering team revealed that all parts were confirmed to contain the incorrect parts than indicated on both the outer and inner packaging.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.Without the return of the actual product involved, our investigation could not proceed.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 10S 10MM X 34CM 130D 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 ; brooks road 1450; memphis, TN 38116 ; 0447940038246
• MDR Report Key: 10421740
• Report Number: 1020279-2020-04011
• Device Sequence Number: 14200877
• Product Code: JDS
• UDI-Device Identifier: 00885556345290
• UDI-Public: 00885556345290
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71675532
• Device Catalogue Number: 71675532
• Device Lot Number: 20DM01466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 09/22/2021; 12/06/2021; 09/29/2022
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 09/23/2021; 12/06/2021; 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• 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
• Patient Sex: Unknown