MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPIR GIGLI SAW BLADE 20; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	210483
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a bka surgery, in the middle of sawing, the spir gigli saw blade 20 broke, it snapped when sawing into bone.No pieces fell into the patient.Then another one was opened (same lot number) and it happened again.The procedure was resumed, after a non-significant delay, with the saw to complete bone cut.No patient injuries were reported.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 22 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The complaint rate and severity of the event were reviewed and revealed that the risk for this particular event is considered low.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.This is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.Based on this investigation, the need for corrective action is not indicated.Should the device or 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: SPIR GIGLI SAW BLADE 20
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 16579987
• Report Number: 1020279-2023-00594
• Device Sequence Number: 4697224
• Product Code: HRY
• UDI-Device Identifier: 03596010102829
• UDI-Public: 03596010102829
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• 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): 06/14/2024

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 Model Number: 210483
• Device Catalogue Number: 210483
• Device Lot Number: 21FT51710B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 06/14/2024
• Date Device Manufactured: 02/14/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown