MAUDE Adverse Event Report: CONMED LARGO 12.5 X 76 X 0.9MM RECIPROCATOR BLADE, RIBBED, COATED, QTY 5; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	5052-179
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Laceration(s) (1946); Foreign Body In Patient (2687)
Date of Event	12/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to date and no photographic evidence has been provided; therefore, the reported event cannot be verified.If the device is returned at a later date, the investigation may be updated and reanalyzed.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 23 reports, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.00002.Per the instructions for use, the user is advised the following: not to use equipment if, upon receipt, package is opened, damaged, or shows any signs of tampering.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
This complaint was created due to the receipt of a medwatch report number 5114481 received on 21mar23.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The report was found to be written against the 00505217900 12.5 x 76 x 0.9mm reciprocator blade, ribbed, coated, qty 5.The report states that on (b)(6) 2022 ¿after total knee replacement, noted saw blade was missing pieces.Xray confirmed piece retained.Required reopening of removal of fragments.¿.For health effects the report listed: laceration(s) and foreign body in patient.Further assessment could not be sent; however, as the reporter elected to not be identified.This report is being raised on the basis of injury due to reopening to retrieve a device fragment that was left in the patient.

• Brand Name: 12.5 X 76 X 0.9MM RECIPROCATOR BLADE, RIBBED, COATED, QTY 5
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 16726569
• Report Number: 1017294-2023-00034
• Device Sequence Number: 20679414
• Product Code: GFA
• UDI-Device Identifier: 10845854000649
• UDI-Public: (01)10845854000649(17)250223(10)1081611
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2025
• Device Model Number: 5052-179
• Device Catalogue Number: 00505217900
• Device Lot Number: 1081611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic