MAUDE Adverse Event Report: CONMED LARGO SPECTRUM II SUTURE HOOK, DISPOSABLE, 45 DEGREE LEFT, QTY 5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	C6381
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
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.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the c6381, spectrum ii suture hook, disposable, 45 degree left, device was being used during a shoulder arthroscopy procedure on 23oct23 when it was reported ¿during shoulder arthroscopic surgery, the spectrum hook broke into two parts at the tube/hook junction.It fell into the patient's shoulder.The surgeon removed the piece with important difficulty given the small size of the device.¿.The procedure was completed and there was no report of injury, medical intervention or extended hospitalization for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The customer reported that the c6381, spectrum ii suture hook, disposable, 45 degree left, device was being used during a shoulder arthroscopy procedure on (b)(6) 2023 when it was reported ¿during shoulder arthroscopic surgery, the spectrum hook broke into two parts at the tube/hook junction.It fell into the patient's shoulder.The surgeon removed the piece with important difficulty given the small size of the device.¿.The procedure was completed and there was no report of injury, medical intervention or extended hospitalization for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was 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 17 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 (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.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.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: SPECTRUM II SUTURE HOOK, DISPOSABLE, 45 DEGREE LEFT, 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: 18324213
• Report Number: 1017294-2023-00120
• Device Sequence Number: 7129523
• Product Code: LXH
• UDI-Device Identifier: 10845854019863
• UDI-Public: (01)10845854019863(17)280301(10)1301920
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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: C6381
• Device Lot Number: 1301920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic