MAUDE Adverse Event Report: CONMED LARGO SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	C6370
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
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 sales representative reported on behalf of the customer that the c6370, spectrum ii suture hook, medium crescent was being used on 03oct22 during a labral repair procedure when it was reported ¿after one use the hook separated from the post in the shoulder.¿ further assessment questioning found that ¿the device did fragment and was retrieved using a king fischer instrument¿.The procedure was completed with the use of an alternate disposable hook and a 2-minute delay was reported during the procedure.There was no report of injury, medical intervention or hospitalization required for the patient.The current status of the patient is ¿good¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that the c6370, spectrum ii suture hook, medium crescent was being used on (b)(6) 2022 during a labral repair procedure when it was reported ¿after one use the hook separated from the post in the shoulder.¿ further assessment questioning found that ¿the device did fragment and was retrieved using a king fischer instrument¿.The procedure was completed with the use of an alternate disposable hook and a 2-minute delay was reported during the procedure.There was no report of injury, medical intervention or hospitalization required for the patient.The current status of the patient is ¿good¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device is not being 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.This is the only complaint for this lot number and failure mode within the past two years.Although this is a reusable device, it is not serviceable.Therefore, a service history is not available for review.A two-year review of complaint history revealed there has been a total of 11 complaints, regarding 12 devices, for this device family and failure mode.During this same time frame 53,135 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 0.0002.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.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT
• 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 ; 3152230184
• MDR Report Key: 15578988
• Report Number: 1017294-2022-00098
• Device Sequence Number: 6763570
• Product Code: LXH
• UDI-Device Identifier: 10845854031117
• UDI-Public: (01)10845854031117(11)220722(10)1258418
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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: C6370
• Device Catalogue Number: C6370
• Device Lot Number: 1258418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic