MAUDE Adverse Event Report: CONMED LARGO SPECTRUM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	C6360
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a customer that the c6360, spectrum ii suture hook, 45° right device was being used during a shoulder rotator cuff procedure on (b)(6) 2024, and "during the operation, while the surgeon was using the instrument, the hook got broken from the hook side broken piece has been retrieved from patient with no harm.".The procedure was completed with a delay of 10-15 minutes.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.The c6362, spectrum ii suture hook, 60° right will be listed as a concomitant device.
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.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
A distributor reported on behalf of a customer that the c6360, spectrum ii suture hook, 45° right device was being used during a shoulder rotator cuff procedure on (b)(6) 2024, and "during the operation, while the surgeon was using the instrument, the hook got broken from the hook side broken piece has been retrieved from patient with no harm." the procedure was completed with a delay of 10-15 minutes.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.The c6362, spectrum ii suture hook, 60° right will be listed as a concomitant device.
Additional 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 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.Avoid mechanical shock or over stressing the instrument which may shorten the life of the instrument.Additionally, the ifu advises the user to not exceed five (5) procedures per limited reuse suture hook.Do not use disposable suture hook for more than one (1) procedure.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: SPECTRUM
• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 20333431
• Report Number: 1017294-2024-00113
• Device Sequence Number: 9628858
• Product Code: LXH
• UDI-Device Identifier: 10845854018385
• UDI-Public: (01)10845854018385(11)181229(10)985884
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: C6360
• Device Lot Number: 985884
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: C6362, SPECTRUM II SUTURE HOOK, 60° RIGHT.; C6362, SPECTRUM II SUTURE HOOK, 60° RIGHT.
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic