MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAST-FIX 360 KPSC AND SLOTTED CANNULA; ACCESSORIES,ARTHROSCOPIC

Model Number	72202674
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fast fix device was received with holes in the inner packaging.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed that it is not in its original packaging.The poly bag is sealed and has a hole in the bag and label.The original outer box, ifu, and chartstik label sheet were not returned.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the material specification found that the pouch seals must withstand 30 inches of water pressure.Test will be performed 30 seconds on aro tester.Pull test strength of 2 lb/in (min.).Package must be free of particulate, debris, hair, etc.Greater than 0.15mm^2.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include an application of unintended, inappropriate or excessive force to the device or inappropriate storage conditions.No containment or corrective actions are recommended at this time.

• Brand Name: FAST-FIX 360 KPSC AND SLOTTED CANNULA
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16896642
• Report Number: 1219602-2023-00670
• Device Sequence Number: 17665334
• Product Code: NBH
• UDI-Device Identifier: 00885554023169
• UDI-Public: 00885554023169
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 72202674
• Device Catalogue Number: 72202674
• Device Lot Number: 2099414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown