MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 100/95; NAIL, FIXATION, BONE

Catalog Number	71677100
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10.Internal reference number: (b)(4).
Event or Problem Description
It was reported that, during an internal fixation, upon opening it was discovered that the inner sterile packaging of the lag/comp screw kit 100/95 was severely damaged.The outer packaging is free of damage.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed that the inner sterile packaging of the was severely damaged.It appears as if the inner packaging is melted or was overheated.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.A review made by the quality engineering team revealed it is likely that the root cause of this complaint is the carton being stuck inside of the shrink-wrapping heat tunnel.Shrink wrapping is the packaging step that occurs after the inner packaging components/product are placed into the carton.Upon investigation by the packaging process engineering team, it is possible for the inner packaging components to be melted, without the carton showing any damage, as seen in this complaint.Before the inner packaging components/product are placed into a carton, any melting of these inner packaging components due to a tray sealing issue would have been identified by the smith and nephew packaging inspection process.A review of complaint history based on the historical data revealed a similar event 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 historical review concluded that there are no prior actions related to this product and event.According to the packaging sequence, the inner tray should be placed inside the outer tray without any deformation (melting) or difficulty to separate one from another.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: LAG/COMP SCREW KIT 100/95
• 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: 19972845
• Report Number: 1020279-2024-01585
• Device Sequence Number: 7001504
• Product Code: JDS
• UDI-Device Identifier: 03596010563323
• UDI-Public: 03596010563323
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71677100
• Device Lot Number: 23MM03626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown