MAUDE Adverse Event Report: CONMED CROSSFT KNOTLESS 4.75 MM SUTURE ANCHOR

Catalog Number	CFK-475S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported anchor was discarded by the user facility; therefore, an evaluation was not completed.However, the complaint was verified by pictures sent by the facility, which showed the damaged anchor.Manufacturing documents were reviewed and all units within this lot met specification before shipment.A two-year review of complaint history revealed a total of four similar complaints with this being the only anchor involved in a procedural approach change from arthroscopic to open.A risk analysis was performed and found to be acceptable.The anchors most likely pulled out due to the patients' poor bone quality.The surgeon was having difficulty getting the tip of the anchor to stay inside the pilot hole when he was tensioning the suture.He used a mallet to force the anchor in the pilot hole which is likely to be the cause of the tip deforming/bending.To reduce the risk of injury to the patient, the product's instructions for use (ifu) provides the following warnings and precautions: -patient should be advised that product materials may cause allergic reactions including but not limited to, foreign body reaction, tissue irritation/inflammation or other allergic reactions.Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.-conditions which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period.-detailed instructions on the use and limitations of the device should be given to the patient before implantation.-the patient should be told to follow the surgeon's protocol for postoperative management.-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.
Event or Problem Description
The user facility reported during and arthroscopic rotator cuff repair procedure, the crossft knotless 4.75 mm implant was unable to deploy due to it being broken at the distal end.The procedure was converted from arthroscopic to an open approach due to this and caused more than a 30-minute surgical delay.Additional information was obtained via email and the patient was said to have poor bone.The doctor was operating with this device for the first time in a clinical setting and was experiencing poor visualization.The patient was opened due to the shoulder being distended for too long and the doctor was unable to establish adequate visualization in order to insert the anchor.This report is raised on the basis of a surgical approach changing from arthroscopic to open.This incident will be reported as a patient injury.
Additional Manufacturer Narrative
Correcction: the awareness date is being corrected from 15-sep-2017 to 11-sep-2017.Conmed (b)(4) provided additional correspondence which indicated notification of this incident was received on 11-sep-2017.

• Brand Name: CROSSFT KNOTLESS 4.75 MM SUTURE ANCHOR
• Common Device Name: CROSSFT KNOTLESS
• Manufacturer (Section D): CONMED; 11311 concept blvd; largo FL 33773
• MDR Report Key: 6938432
• Report Number: 1017294-2017-00091
• Device Sequence Number: 1297857
• Product Code: MBI
• UDI-Device Identifier: 20845854044602
• UDI-Public: (01)20845854044602(17)181113(10)833672
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2018
• Device Catalogue Number: CFK-475S
• Device Lot Number: 833672
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR