MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYNOVATOR BLADE BOXED4.5 EP-1; SAW, POWERED, AND ACCESSORIES

Catalog Number	7205310
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during set up an air leakage was found in the sterile package of three (3) synovator blades.There was a back-up device available and a surgical delay less than 30 minutes was reported.There was no patient involvement.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the device was received for evaluation at the manufacturing site; however, a physical product evaluation was not possible.An analysis of the customer provided images shows the devices in their original packaging, the packaging has been damaged, and it's evident that the seal is breaking.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no 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 assembly inspection of disposable blades and burrs, found that the seal area must be inspected to ensure a complete seal/sterile barrier system.The following are not acceptable: voids, channels, incomplete seals, particulates/foreign material within the seal or extreme glazing.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the failure include an inadvertent impact event that could have occurred during device transportation, rough shipping and handling, or at customer site.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H10: h3, h6: the device was received for evaluation at the manufacturing site; however, a physical product evaluation was not possible.An analysis of the customer provided images shows the devices in their original packaging, the packaging has been damaged, and it's evident that the seal is breaking.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no 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 assembly inspection of disposable blades and burrs, found that the seal area must be inspected to ensure a complete seal/sterile barrier system.The following are not acceptable: voids, channels, incomplete seals, particulates/foreign material within the seal or extreme glazing.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the failure include an inadvertent impact event that could have occurred during device transportation, rough shipping and handling, or at customer site.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: SYNOVATOR BLADE BOXED4.5 EP-1
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• 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: 19140810
• Report Number: 1219602-2024-00836
• Device Sequence Number: 7548109
• Product Code: HAB
• UDI-Device Identifier: 03596010251381
• UDI-Public: 03596010251381
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2024

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 Expiration Date: 06/02/2025
• Device Catalogue Number: 7205310
• Device Lot Number: 50876474
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/26/2024; 10/30/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 07/01/2024; 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown