MAUDE Adverse Event Report: CONMED LARGO PRESSFT 2.6; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number NP261

Device Problem Material Fragmentation (1261)

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

Event Date 06/08/2022

Event Type  malfunction  

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.Device will not be returned for an evaluation as it was disposed of at the hospital.

Event Description

The sales representative reported on behalf of the customer that the device, np261, pressft 2.6 was being used on (b)(6) 2022 during an instability repair procedure when it was reported that ¿case was assisted by distributor staff on placement of peek anchor on 3' o clock position.Post drilling it was directly punched in till the laser line and driver removed and knot was tried that time it was seen the peek anchor is split.Another all suture yknot flex anchor was placed on 5'30 position post anchor fixation on knot tying the anchor bailed out." follow up assessment questioning found that the device did fragment and "it was retrieved using a grasper".The procedure was completed with the use of an alternative device and there was no report of injury, medical intervention or hospitalization to patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned for evaluation, but photographic evidence has been provided that confirmed the reported issue.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 to inspect all instruments for damage prior to use.Ensure the anchor is properly seated on the driver tip prior to and during implantation.Avoid lateral loading while inserting the pressft and genesys pressft suture anchors.Maintain proper alignment during insertion of the anchor and disengagement of the driver.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the device, np261, pressft 2.6 was being used on (b)(6) 2022 during an instability repair procedure when it was reported that ¿case was assisted by distributor staff on placement of peek anchor on 3' o clock position.Post drilling it was directly punched in till the laser line and driver removed and knot was tried that time it was seen the peek anchor is split.Another all suture yknot flex anchor was placed on 5'30 position post anchor fixation on knot tying the anchor bailed out." follow up assessment questioning found that the device did fragment and "it was retrieved using a grasper".The procedure was completed with the use of an alternative device and there was no report of injury, medical intervention or hospitalization to patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: PRESSFT 2.6
• 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: samantha dewberry ; 525 french rd; utica, NY 13502 ; 3152230184
• MDR Report Key: 14753357
• MDR Text Key: 302116929
• Report Number: 1017294-2022-00073
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10845854036631
• UDI-Public: (01)10845854036631(17)270308(10)1212885
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K112965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NP261
• Device Lot Number: 1212885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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 Ethnicity: Non Hispanic