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

Catalog Number	CFBC-5502B
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, cfbc-5502b, 5.5mm genesys crossft suture anchor, was being used on (b)(6) 2022 during a rotator cuff repair procedure when it was reported that the ¿anchor broke into multiple pieces when the surgeon tried implanting it into patient's shoulder.¿ the procedure was completed with an alternate device with a 2 minute delay.Further assessment found that dr.(b)(6) was the surgeon, the device was retrieved, the intervention was opening a new anchor, the patient wasn't injured, the patient wasn't effected, there was no extended stay needed.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.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 9 complaints, regarding 9 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 (b)(4).Per the instructions for use, the user is advised to inspect all instruments for damage prior to use.Proper orientation and alignment of instruments is important during implantation of the genesys crossft suture anchor to minimize possible breakage of the anchor.Breakage of the genesys crossft suture anchor is possible if: a) the bone punch or tap is not inserted to the proper depth; b) the genesys crossft suture anchor is not properly aligned with the pilot hole; c) the genesys crossft suture anchor is loose or not securely attached on the driver; d) the genesys crossft suture anchor inserter is used for prying; e) the genesys crossft suture anchor is advanced too deep; f) 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 or Problem Description
The sales representative reported on behalf of the customer that the device, cfbc-5502b, 5.5mm genesys crossft suture anchor, was being used on 8april22 during a rotator cuff repair procedure when it was reported that the ¿anchor broke into multiple pieces when the surgeon tried implanting it into patient's shoulder.¿ the procedure was completed with an alternate device with a 2 minute delay.Further assessment found that dr.Duellman was the surgeon, the device was retrieved, the intervention was opening a new anchor, the patient wasn't injured, the patient wasn't effected, there was no extended stay needed.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 5.5MM GENESYS CROSSFT SUTURE ANCHOR
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, 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: courtney pomichter ; 525 french rd; utica, NY 13502 ; 3156243170
• MDR Report Key: 14171976
• Report Number: 1017294-2022-00047
• Device Sequence Number: 17383926
• Product Code: MAI
• UDI-Device Identifier: 10845854042472
• UDI-Public: (01)10845854042472(17)240816(10)1188361
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K101100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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: 08/16/2024
• Device Catalogue Number: CFBC-5502B
• 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: 04/08/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic