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

Model Number	71675532
Medical Device Problem Codes	Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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.
Additional Manufacturer Narrative
H7, h9: recall number added.

• 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: holly topping ; 1450 brooks road; memphis, TN 38116 ; 5123913905
• MDR Report Key: 10697515
• Report Number: 1020279-2020-05501
• Device Sequence Number: 14217695
• Product Code: JDS
• UDI-Device Identifier: 00885556345290
• UDI-Public: 00885556345290
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/26/2022

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?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 09/08/2021; 09/08/2021; 09/22/2022
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 09/09/2021; 12/08/2021; 09/27/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown