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

Model Number	C6360
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
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
The distributor reported on behalf of their customer that the c6360, spectrum ii suture hook, 45 degree right, was being used during a shoulder scope procedure on (b)(6) 2023 when it was reported, ¿broken during surgery.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed without any reported delay.Further assessment request found that device fragmented during the procedure, when applying force to cut through the tissue and the fragment was removed using forceps.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned and no photographic evidence has been provided therefore the reported event 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 17 complaints, regarding 18 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).Per the instructions for use, the user is advised to avoid lateral stresses to the instruments or device function may be compromised.There is increased risk of hook or needle breakage and unintentional patient injury may result.The user is also advised to not exceed five (5) procedures per limited reuse suture hook.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the c6360, spectrum ii suture hook, 45 degree right, was being used during a shoulder scope procedure on (b)(6) 2023 when it was reported, ¿broken during surgery.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed without any reported delay.Further assessment request found that device fragmented during the procedure, when applying force to cut through the tissue and the fragment was removed using forceps.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: SPECTRUM II SUTURE HOOK, 45 DEGREE RIGHT
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 16477034
• Report Number: 1017294-2023-00016
• Device Sequence Number: 11547407
• 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): 03/20/2023

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 Model Number: C6360
• 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: 02/15/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 03/20/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic