MAUDE Adverse Event Report: CONMED LARGO 5.5MM CROSSFT SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	CFP-5503B
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer, that cfp-5503b, 5.5mm crossft suture anchor was being used during an unknown procedure on an unknown date when it was reported ¿when removing the driver, the piece of metal that the peek anchor sits on broke off and was floating in the joint.This happened at riverwalk surgery center, the anchor was implanted, and they were able to retrieve the piece of metal.¿.There was no report of injury, medical intervention or extended hospitalization to the patient or user.This report is being raised on the reported 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.H3 other text : device not yet received.
Additional Manufacturer Narrative
The device will not be returned for evaluation, but photographic evidence has been provided.The root cause cannot be determined, however, based upon the photo, and the ifu the likely cause of this event was excessive force was used on the driver.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.(b)(4).Per the instructions for use, the user is advised that preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the implant are important considerations in the successful utilization of this device.Surgeon must choose proper implant size based on specific procedure and patient history.Avoid lateral loading while inserting the suture anchor.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 cfp-5503b, 5.5mm crossft suture anchor was being used during an unknown procedure on an unknown date when it was reported "when removing the driver, the piece of metal that the peek anchor sits on broke off and was floating in the joint.This happened at (b)(6), the anchor was implanted, and they were able to retrieve the piece of metal." there was no report of injury, medical intervention or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: 5.5MM CROSSFT SUTURE ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18214998
• Report Number: 1017294-2023-00109
• Device Sequence Number: 6622283
• Product Code: MBI
• UDI-Device Identifier: 10845854042588
• UDI-Public: (01)10845854042588(17)280920(10)1342655
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091549
• 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): 01/09/2024

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 Catalogue Number: CFP-5503B
• Device Lot Number: 1342655
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic