MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 13MM X 37CM; NAIL, FIXATION, BONE

Catalog Number	71655337
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, it was noticed that the package of one (1) meta-nail tibial 13mm x 37cm was left unsealed inside a sealed outer packaging.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
D4, h3, h4, h6: the associated packaging was returned and evaluated.The visual inspection revealed that the outer pouch was not completely sealed.This inspection was conducted by naked eye.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 the reason for this issue was the omission of the heat seal operation of the outer pouch for this particular product, causing the product to lose its sterility.Thorough visual inspections should be carefully performed to identify this failure, which would reduce the risk of other orders being affected.Furthermore, according to the packaging sequence, the component should be carefully placed into the sleeve.Then, the sleeve will be sealed on the open end of pouch.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we do have evidence to conclude that the product failed to meet specifications at the time of manufacture.Based on this investigation, the need for corrective action is not 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.

• Brand Name: META-NAIL TIBIAL 13MM X 37CM
• 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: 19414052
• Report Number: 1020279-2024-01031
• Device Sequence Number: 12888660
• Product Code: JDS
• UDI-Device Identifier: 03596010612977
• UDI-Public: 03596010612977
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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
• Device Catalogue Number: 71655337
• Device Lot Number: 21AM03171
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown