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

Catalog Number	C6361
Medical Device Problem Codes	Material Fragmentation (1261); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that the c6361, spectrum ii suture hook, 45 degree left device was being used during a shoulder arthroscopy procedure on an unknown date, and ¿the hook broke off in the patient's tendon.The surgeon was able to remove the piece of hook without causing any damage.The incident lengthened the operating time (duration unknown) and added stress for the surgeon¿.The procedure was completed with 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.
Additional 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 or Problem Description
A customer reported that the c6361, spectrum ii suture hook, 45 degree left device was being used during a shoulder arthroscopy procedure on an unknown date, and ¿the hook broke off in the patient's tendon.The surgeon was able to remove the piece of hook without causing any damage.The incident lengthened the operating time (duration unknown) and added stress for the surgeon¿.The procedure was completed with 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.
Additional Manufacturer Narrative
The evaluation of returned used device c6361 performed per print c6361 found hook broken off and detached from shaft.Also, the shaft found bent.The broken hook was not returned for the evaluation.The root cause cannot be determined, however, based upon the evaluation, and photo the likely cause is excessive force or overuse 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.(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.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: SPECTRUM II SUTURE HOOK, 45 DEGREE LEFT
• 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: 18719749
• Report Number: 1017294-2024-00021
• Device Sequence Number: 11697716
• Product Code: LXH
• UDI-Device Identifier: 10845854018668
• UDI-Public: (01)10845854018668(11)221012(10)1276111
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

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: C6361
• Device Lot Number: 1276111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic