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

Model Number 71675532

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2020

Event Type  Injury  

Event Description

It was reported that during surgery a intertan 10s 10mm x 34cm 130d right nail was opened and inside the box was a 10 x 34 nail and sticker confirmed as well.After putting the nail down and feeling some resistance the doctor checked x-rays and saw the nail was way too long.The doctor took the nail out and saw that it was a 10mm x 38cm 125d right nail as marked on the nail.Procedure was delayed for less than 30 min and an s+n backup device was available.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was returned without its original packaging.The device shows signs of attempted use.Additional devices were pulled from inventory and confirmed the stated failure mode.The clinical medical investigation concluded that photos of the intertan nail and sticker was provided for review and confirm the reported.Per e-mail communication, the patient was not harmed due to the reported events and the out come was reported as ok.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.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.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.

Manufacturer Narrative

G3, h2, h3, and h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was returned without its original packaging.The device shows signs of attempted use.Additional devices were pulled from inventory and confirmed the stated failure mode.The clinical medical investigation concluded that photos of the intertan nail and sticker was provided for review and confirm the reported.Per e-mail communication, the patient was not harmed due to the reported events and the out come was reported as ok.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.A complaint history review found related failures for the same 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.As a result of the investigation, several process improvements were implemented related to training, process monitoring and in process inspection.In addition, containment and remedial actions were performed for the impacted finished product.We will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.H6: update codes.

Manufacturer Narrative

H7, h9: recall number added.

• Brand Name: INTERTAN 10S 10MM X 34CM 130D RIGHT
• Type of Device: 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: holly topping ; 1450 brooks road; memphis, TN 38116 ; 5123913905
• MDR Report Key: 10697515
• MDR Text Key: 211895698
• Report Number: 1020279-2020-05501
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556345290
• UDI-Public: 00885556345290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71675532
• Device Catalogue Number: 71675532
• Device Lot Number: 20DM01466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0772-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention