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

Model Number	71675532
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an internal fixation surgery, it was noticed that a 38cm nail was inside the intertan 10s 10mm x 34cm 130d right box.Surgery was resumed, after a non-significant delay, with a sn back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Section h3, h6: the device was not received for evaluation.No information was available about the status of the package using universal carrier searches.This may be because the package has not been sent yet or that the tracking number provided is invalid.However the pictures were reviewed, and revealed the discrepancy between the size of the device and the size on the label and package.A review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.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.A historical review concluded that this event was previously identified and addressed through several process improvements related to training, process monitoring and in process inspection.The potential probable cause for this event is likely a manufacturing process error caused by inadequate line clearance when producing more than one batch.In addition, this event was addressed through a market removal of the product.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.

• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15349687
• Report Number: 1020279-2022-03928
• Device Sequence Number: 12129483
• Product Code: JDS
• UDI-Device Identifier: 00885556345290
• UDI-Public: 00885556345290
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 09/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTERTAN 10S 10MM X 38CM 125D RIGHT, LOT#:20CM2527
• Patient Sex: Unknown