MAUDE Adverse Event Report: CONMED LARGO SPECTRUM II SUTURE HOOK, DISPOSABLE, 45 DEGREE RIGHT, QTY 5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number C6380

Device Problem Material Fragmentation (1261)

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

Event Date 06/20/2023

Event Type  malfunction  

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.

Event Description

The sales representative reported on behalf of the customer that the c6380 spectrum ii suture hook, disposable, 45 degree right, qty 5 was being used on (b)(6) 2023 during a shoulder arthroscopy procedure and ¿the hook broke during the operation.Another hook was used to complete the procedure - device fully recovered.¿.There was no impact or injury to the patient.The procedure was completed with another hook.Per assessment it was found "the broken end of the hook could be recovered in its entirety.¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Evaluation of the returned used device was performed, and found hook broken off and detached from shaft.Broken hook was not returned for the evaluation.At this time the root cause of the event cannot be determined, but based on the evaluation and photos provided, a likely cause of this issue is excessive force was applied.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 17 reports, regarding 17 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 the following: if the hook or needle bends during use, immediately discontinue use and discard.There is an increased risk of hook or needle breakage and unintentional patient injury may result.Avoid lateral stresses to the instruments or device function may be compromised.There is an increased risk of hook or needle breakage and unintentional patient injury may result.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the c6380 spectrum ii suture hook, disposable, 45 degree right, qty 5 was being used on (b)(6) 2023 during a shoulder arthroscopy procedure and ¿the hook broke during the operation.Another hook was used to complete the procedure - device fully recovered.¿.There was no impact or injury to the patient.The procedure was completed with another hook.Per assessment it was found "the broken end of the hook could be recovered in its entirety.¿ this report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: SPECTRUM II SUTURE HOOK, DISPOSABLE, 45 DEGREE RIGHT, QTY 5
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 17288483
• MDR Text Key: 318842623
• Report Number: 1017294-2023-00063
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10845854018545
• UDI-Public: (01)10845854018545(10)270807(30)1(17)1262869
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C6380
• Device Lot Number: 1262869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic