MAUDE Adverse Event Report: CONMED LARGO SPECTRUM MVP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	C6400
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the c6400, spectrum mvp suture passer, disposable, crescent, medium device was used on (b)(6) 2024, and ¿during a labral repair, a very tiny piece of the "fork" that passes the suture through the mvp broke off which we assume broke inside the patient.Surgeon did not notice it broke until we went to reload another suture.The small piece was not recovered but to our knowledge no harm has been done to the patient.The piece was much too small for fluoroscopy so we did not attempt to find it in the patient.¿ follow-up assessment found that "no x-ray or ultrasound was attempted, surgeon felt that the piece was way to small to find and felt the scope would suck it up with suction.The piece was extremely small, the surgeon believes it broke off inside the patient but since it was so small he feels there is a very good chance that the saline that is pumped in during arthroscopy¿s just naturally sucked the fragment up into the neptune and is hoping it was removed from the patients body that way".The fragment was searched for outside of the patient but not found.The surgery was completed as normal, with the use of "another mvp".There was no delay, and no medical/surgical intervention or extended hospitalization required for the patient, who is "doing well with no issues".This report is being raised due to the reported injury of potential retained foreign body due to fragmentation which was not located.
Event or Problem Description
A sales representative reported on behalf of a customer that the c6400, spectrum mvp suture passer, disposable, crescent, medium device was used on 21nov24, and ¿during a labral repair, a very tiny piece of the "fork" that passes the suture through the mvp broke off which we assume broke inside the patient.Surgeon did not notice it broke until we went to reload another suture.The small piece was not recovered but to our knowledge no harm has been done to the patient.The piece was much too small for fluoroscopy so we did not attempt to find it in the patient.¿.Follow-up assessment found that "no x-ray or ultrasound was attempted, surgeon felt that the piece was way to small to find and felt the scope would suck it up with suction.The piece was extremely extremely small, the surgeon believes it broke off inside the patient but since it was so small he feels there is a very good chance that the saline that is pumped in during arthroscopy¿s just naturally sucked the fragment up into the neptune and is hoping it was removed from the patients body that way".The fragment was searched for outside of the patient but not found.The surgery was completed as normal, with the use of "another mvp".There was no delay, and no medical/surgical intervention or extended hospitalization required for the patient, who is "doing well with no issues".This report is being raised due to the reported injury of potential retained foreign body due to fragmentation which was not located.
Additional Manufacturer Narrative
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.A two-year lot history review shows a total of one device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of four reports, regarding five devices, for this device family and failure mode.During this same time frame 9,507 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 0.0005.Per the instructions for use, the user is advised the following: avoid lateral stresses to the instrument or device function may be compromised and unintentional patient injury may result.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: SPECTRUM MVP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 20937813
• Report Number: 1017294-2024-00155
• Device Sequence Number: 8054679
• Product Code: LXH
• UDI-Device Identifier: 10845854019894
• UDI-Public: (01)10845854019894(17)250403(10)1344564
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: 04/03/2025
• Device Catalogue Number: C6400
• Device Lot Number: 1344564
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic