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

Model Number C6360

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/28/2023

Event Type  Injury  

Event Description

The customer reported that the device c6360, spectrum ii suture hook, 45 degree right, was being used on (b)(6) 2023 during a shoulder instability procedure when it was reported ¿spectrum hook right 45 degree broke when passing the tissue.Try to take it out, but the piece broke when to antero inferior axillary pouch.So couldn¿t take it out.¿.The procedure was completed without the use of an alternate device and a 1-hour delay was reported.There was no report of medical intervention, or hospitalization required for the patient.This report is being raised on the reported injury due to patient retaining a foreign object.

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.We will continue to monitor for trends through the complaint system to assure patient safety.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was 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.(b)(4).Per the instructions for use, the user is advised that 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.Void 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 customer reported that the device c6360, spectrum ii suture hook, 45 degree right, was being used on (b)(6) 2023 during a shoulder instability procedure when it was reported ¿spectrum hook right 45 degree broke when passing the tissue.Try to take it out, but the piece broke when to antero inferior axillary pouch.So couldn¿t take it out.¿.The procedure was completed without the use of an alternate device and a 1-hour delay was reported.There was no report of medical intervention, or hospitalization required for the patient.This report is being raised on the reported injury due to patient retaining a foreign object.

• Brand Name: SPECTRUM II SUTURE HOOK, 45 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 16960349
• MDR Text Key: 315533630
• Report Number: 1017294-2023-00047
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10845854018385
• UDI-Public: (01)10845854018385(11)220218(10)1227793
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C6360
• Device Catalogue Number: C6360
• Device Lot Number: 1227793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic