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

Catalog Number	71675532
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during surgery, the packaging of the implant to be used (intertan 10s 10mm x 38cm 125d right) contained a different implant (intertan 10s 10mm x 34cm 130d right).The procedure was finished with a surgical delay of less than 30 minutes by using a smith and nephew back up device.The patient was not harmed.
Additional Manufacturer Narrative
Additional information was received for this event.Find new information in section: d4 (lot number).
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 was manufactured in 2020 and shows signs of attempted use.Additional devices were pulled from inventory and confirmed the stated failure mode.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.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
H10.Results of investigation: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode as the device was returned without its original packaging.However additional devices were pulled from inventory and confirmed the stated failure mode.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.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 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 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 ; 1450 brooks road; memphis, TN 38116 ; 0447940038246
• MDR Report Key: 10118477
• Report Number: 1020279-2020-01988
• Device Sequence Number: 2153600
• Product Code: JDS
• UDI-Device Identifier: 00885556345290
• UDI-Public: 885556345290
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71675532
• Device Lot Number: 20DM01466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 06/09/2020; 06/09/2020; 12/06/2021; 09/27/2022
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 06/12/2020; 02/26/2021; 12/06/2021; 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2020
• 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: 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