MAUDE Adverse Event Report: CONMED LARGO SPECTRUM II SUTURE HOOK, 60 DEGREE RIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number C6362

Device Problem Material Fragmentation (1261)

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

Event Date 11/01/2021

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.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, c6362, spectrum ii suture hook, 60 degree right, was being used on (b)(6) 2021 during an unknown procedure and the ¿needle broke off at the weld interface between the shaft and needle tip during use in surgery.The patient was stable during and after the surgery and no adverse events were reported.No foreign bodies left in the patient.¿ there was no report of impact or injury to the patient.Further assessment has been sent; however, no response has been received to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Event Description

The sales representative reported on behalf of the customer that the device, c6362, spectrum ii suture hook, 60 degree right, was being used on (b)(6) 2021 during an unknown procedure and the ¿needle broke off at the weld interface between the shaft and needle tip during use in surgery.The patient was stable during and after the surgery and no adverse events were reported.No foreign bodies left in the patient.¿ there was no report of impact or injury to the patient.Further assessment has been sent; however, no response has been received to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Reported event is confirmed.Customer event ¿needle broke off at the weld interface between the shaft and needle tip during use in surgery¿ was confirmed.Customer complaint of device broke off at the weld was confirmed.Visual examination of returned used device, item c6362 found devices broken off at the laser weld joint location.The suture hooks were not returned for evaluation.Although this is a reusable device, it is not serviceable.Therefore, a service history is not available for review.A device history review found no abnormalities that would contribute to this reported event.A two-year review of complaint history revealed there has been a total of 12 complaints, regarding 13 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: prior to use, always inspect suture needle for damage (i.E., worn, dull, bent or cracked).Prior to use, always inspect and test the instrument for proper function by passing usp #1 monofilament through handle and hook.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

B5 updated with additional information received.All other information in report is correct and remains unchanged.Reported event is confirmed.Customer event ¿needle broke off at the weld interface between the shaft and needle tip during use in surgery¿ was confirmed.Customer complaint of device broke off at the weld was confirmed.Visual examination of returned used device, item c6362 found devices broken off at the laser weld joint location.The suture hooks were not returned for evaluation.Although this is a reusable device, it is not serviceable.Therefore, a service history is not available for review.A device history review found no abnormalities that would contribute to this reported event.(b)(4).Per the instructions for use, the user is advised the following: prior to use, always inspect suture needle for damage (i.E., worn, dull, bent or cracked).Prior to use, always inspect and test the instrument for proper function by passing usp #1 monofilament through handle and hook.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Update: assessment answers received.The surgery was a labral repair.The procedure was completed with no delay.The fragment was retrieved using a hemostat.The sales representative reported on behalf of the customer that the device, c6362, spectrum ii suture hook, 60 degree right, was being used on 01nov2021, during an unknown procedure and the ¿needle broke off at the weld interface between the shaft and needle tip during use in surgery.The patient was stable during and after the surgery and no adverse events were reported.No foreign bodies left in the patient.¿ there was no report of impact or injury to the patient.Further assessment has been sent; however, no response has been received to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: SPECTRUM II SUTURE HOOK, 60 DEGREE RIGHT
• 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: 12843494
• MDR Text Key: 282270316
• Report Number: 1017294-2021-00360
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C6362
• Device Lot Number: 1042910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic