MAUDE Adverse Event Report: CONMED LARGO 4.5MM STERLING, LIGHTNING, 6 EA; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	H9133
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the h9133, 4.5mm sterling, lightning, 6 ea was used during an elbow arthroscopy on the date of (b)(6) 2023, when it was reported, ¿during the surgical procedure the blade bent and broken in an abnormal way, the same thing happens when opening other pieces same lot.¿after further assessment it was concluded the device did fragment into the surgical site, but it was retrieved with a basket grasper.The procedure was completed with an unknown alternate device and a 30 minute delay.There was no patient or user injury, prolonged hospitalization, or medical intervention.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
The reported event of ¿blade bent and broke¿ was inconclusive.The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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 11 reports, regarding 21 devices, for this device family and failure mode.(b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the h9133, 4.5mm sterling, lightning, 6 ea was used during an elbow arthroscopy on the date of 21feb23, when it was reported, ¿during the surgical procedure the blade bent and broken in an abnormal way, the same thing happens when opening other pieces same lot.¿.After further assessment it was concluded the device did fragment into the surgical site, but it was retrieved with a basket grasper.The procedure was completed with an unknown alternate device and a 30 minute delay.There was no patient or user injury, prolonged hospitalization, or medical intervention.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Update: customer returned for evaluation a total of 6 blades, 3 open packages and 3 still unopened in original package.Examination of returned item, h9133, qty of 6 could not confirm the reported problem.No fault found.Examination performed per print a30-532-002, rev- af and print a30-532-639, rev- ad could not find any discrepancies with print critical dimensions.The reported event of ¿blade bent and broke¿ was inconclusive.The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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 11 reports, regarding 21 devices, for this device family and failure mode.(b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the h9133, 4.5mm sterling, lightning, 6 ea was used during an elbow arthroscopy on the date of (b)(6) 2023, when it was reported, ¿during the surgical procedure the blade bent and broken in an abnormal way, the same thing happens when opening other pieces same lot.¿.After further assessment it was concluded the device did fragment into the surgical site, but it was retrieved with a basket grasper.The procedure was completed with an unknown alternate device and a 30 minute delay.There was no patient or user injury, prolonged hospitalization, or medical intervention.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 4.5MM STERLING, LIGHTNING, 6 EA
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 16588496
• Report Number: 1017294-2023-00021
• Device Sequence Number: 5895762
• Product Code: GFF
• UDI-Device Identifier: 10845854029671
• UDI-Public: (01)10845854029671(17)260805(10)1185230
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2023

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 Expiration Date: 08/05/2026
• Device Model Number: H9133
• Device Catalogue Number: H9133
• Device Lot Number: 1185230
• 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: 02/22/2023
• Supplement Date Received by Manufacturer: 04/18/2023; 05/11/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/24/2023; 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic