MAUDE Adverse Event Report: CONMED LARGO 4.5MM CROSSFT SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number CFP-4502

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2022

Event Type  malfunction  

Event Description

The distributor reported on behalf of their customer that 4.5mm crossft suture anchor was being used during an fifth finger flexor reconstruction procedure on (b)(6) 2022, when it was reported, ¿the implant fractures when entering the hole¿.The procedure was completed with the use of an alternate super revo ft device and a 4 minute delay was reported in the procedure.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of injury, medical intervention, or hospitalization.This report is being raised on the basis of injury due to possible retained foreign object in the patient.

Manufacturer Narrative

The device is 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.This issue will continue to be monitored through the complaint system to assure patient safety.Not yet received the device.

Event Description

Update: per assessment received on 1-13-23, the fragments were retrieved.The event date was 13jul22.The distributor reported on behalf of their customer that cfp-4502 4.5mm crossft suture anchor was being used during an fifth finger flexor reconstruction procedure on (b)(6) 2022, when it was reported, ¿the implant fractures when entering the hole.¿.The procedure was completed with the use of an alternate super revo ft device and a 4 minute delay was reported in the procedure.Further assessment, it was reported the fragments were retrieved.There was no report of injury, medical intervention, or hospitalization.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Corrections.B1 changed from adverse event to product problem.B2 unchecked "other serious".B5 changed surgical event date.E3 changed the initial reporters job title.H1 changed to malfunction.H10 made changes.Added corrections due to assessment answers received on 1/13/2023.Examination of the returned used device, item cfp-4502 confirms the report of the problem and found the implant cracked and still attached to the driver.Suspect the pilot hole on the bone was not drilled correctly.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 8 reports, regarding 8 devices, for this device family and failure mode.During this same time frame 33,596 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 0.0002.Per the instructions for use, the user is advised the following: the user is advised proper orientation and alignment of instruments is important during implantation of the crossft suture anchor to minimize possible breakage of the anchor.Breakage of the crossft suture anchor is possible if: the bone punch or tap is not inserted to the proper depth, the crossft suture anchor is not properly aligned with the pilot hole, the crossft suture anchor is loose or not securely attached on the driver, the crossft suture anchor inserter is used for prying, the crossft suture anchor is advanced too deep.A small amount of forward pressure is not applied while rotating the handle.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

Examination of the returned used device, item cfp-4502 confirms the report of the problem and found the implant cracked and still attached to the driver.Suspect the pilot hole on the bone was not drilled correctly.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 8 reports, regarding 8 devices, for this device family and failure mode.During this same time frame 33,596 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 0.0002.Per the instructions for use, the user is advised the following: the user is advised proper orientation and alignment of instruments is important during implantation of the crossft suture anchor to minimize possible breakage of the anchor.Breakage of the crossft suture anchor is possible if: the bone punch or tap is not inserted to the proper depth, the crossft suture anchor is not properly aligned with the pilot hole, the crossft suture anchor is loose or not securely attached on the driver, the crossft suture anchor inserter is used for prying, the crossft suture anchor is advanced too deep.A small amount of forward pressure is not applied while rotating the handle.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of their customer that 4.5mm crossft suture anchor was being used during an fifth finger flexor reconstruction procedure on (b)(6) 2022, when it was reported, ¿the implant fractures when entering the hole.¿.The procedure was completed with the use of an alternate super revo ft device and a 4 minute delay was reported in the procedure.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of injury, medical intervention, or hospitalization.This report is being raised on the basis of injury due to possible retained foreign object in the patient.

• Brand Name: 4.5MM CROSSFT SUTURE ANCHOR
• Type of Device: 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: aubrey nardozzi ; 11311 concept blvd; largo, FL 33773 ; 7273995288
• MDR Report Key: 16035049
• MDR Text Key: 306006720
• Report Number: 1017294-2022-00115
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10845854014233
• UDI-Public: (01)10845854014233(17)270131(30)1(10)1223714
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K091549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CFP-4502
• Device Lot Number: 1223714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic