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

Model Number	C6385
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
International complaints reported on behalf of the customer that the device, c6385, spectrum ii suture hook, disposable, small, was being used during a shoulder arthroscopy procedure on (b)(6) 2022 when it was reported ¿during surgery the tip of the suture hook broke inside the patient, and it was not possible to retrieve the broken part as it would have caused more damage to the patient.The broken tip remained inside the patient while confirmation of mri¿.Further assessment questioning found that the device was ¿impossible to remove¿ and the procedure was completed with a 15-minute delay.The patient's current status was reported as "good".There was no report of extended hospitalization for the patient this report is being raised on the basis of injury due to retained foreign object.
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
International complaints reported on behalf of the customer that the device, c6385, spectrum ii suture hook, disposable, small, was being used during a shoulder arthroscopy procedure on (b)(6) 2022 when it was reported ¿during surgery the tip of the suture hook broke inside the patient, and it was not possible to retrieve the broken part as it would have caused more damage to the patient.The broken tip remained inside the patient while confirmation of mri.¿ further assessment questioning found that the device was ¿impossible to remove¿ and the procedure was completed with a 15-minute delay.The patient's current status was reported as "good".There was no report of extended hospitalization for the patient this report is being raised on the basis of injury due to retained foreign object.
Additional Manufacturer Narrative
G3.A correction was made to show that the initial mdr submitted had the incorrect awareness date.The original awareness date reported was 12dec22 and has been corrected to show 07dec22.Manufacturer narrative: the device will not be returned for evaluation and no photographic evidence has been provided.Therefore, a device malfunction cannot be verified.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 13 complaints, regarding 14 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 0.0003.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.Do not use if parts are broken, cracked or worn, or device function may be compromised.There is an increased risk of hook or needle breakage, and unintentional patient injury may result.This issue will continue to be monitored through the complaint system to assure patient safety.
Additional Manufacturer Narrative
The device will not be returned for evaluation and no photographic evidence has been provided.Therefore, a device malfunction cannot be verified.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 13 complaints, regarding 14 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 0.0003.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.Do not use if parts are broken, cracked or worn, or device function may be compromised.There is an increased risk of hook or needle breakage, and unintentional patient injury may result.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
International complaints reported on behalf of the customer that the device, c6385, spectrum ii suture hook, disposable, small, was being used during a shoulder arthroscopy procedure on (b)(6) 2022 when it was reported ¿during surgery the tip of the suture hook broke inside the patient, and it was not possible to retrieve the broken part as it would have caused more damage to the patient.The broken tip remained inside the patient while confirmation of mri.¿ further assessment questioning found that the device was ¿impossible to remove¿ and the procedure was completed with a 15-minute delay.The patient's current status was reported as "good".There was no report of extended hospitalization for the patient this report is being raised on the basis of injury due to retained foreign object.

• Brand Name: SPECTRUM II SUTURE HOOK, DISPOSABLE, SMALL CRESCENT, QTY 5
• Common Device Name: 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 16033535
• Report Number: 1017294-2022-00114
• Device Sequence Number: 20701807
• Product Code: LXH
• UDI-Device Identifier: 10845854018699
• UDI-Public: (01)10845854018699(17)240211(30)1(10)998892
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2024
• Device Model Number: C6385
• Device Catalogue Number: C6385
• Device Lot Number: 998892
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 12/29/2022; 01/23/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 01/17/2023; 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MRI; MRI; MRI
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic