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

Catalog Number C6360

Device Problem Material Fragmentation (1261)

Patient Problem Laceration(s) (1946)

Event Date 04/07/2023

Event Type  Injury  

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.

Event Description

This complaint was created due to the receipt of a mir report mhra reference number: (b)(4), received on 7jul23.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The report was found to be written against the c6380 spectrum ii suture hook, disposable, 45 degree right.The report states that on 7apr23 ¿during arthroscopic stabilization of shoulder, the end of a 45 degree suture hook snapped off whilst inside the patients joint space.The operating surgeon had to convert to an open procedure in order to retrieve the broken instrument¿.After further assessment it was found that there was no extended hospital stay for the patient.Patient's current status was reported as "outpatient".The procedure was completed with a delay of 30 minutes to an hour.This report is being raised on the basis of injury due to converting to an open procedure.

Manufacturer Narrative

Correction: d4 catalog was changed from c6380 to c6360.Manufacturer report: reported event of ¿hook snapped off¿ is confirmed.The device has not been returned to date, but photographic evidence has been provided.If the device is returned, at a later date, the investigation may be updated and reanalyzed.Root cause cannot be determined, however, based upon photos and the ifu; a possible cause of this event could be excessive force.A two-year lot history review cannot be conducted as a valid lot number was not provided.A device history record review cannot be conducted as a valid lot number was not provided.A two-year review of complaint history revealed there has been a total of 17 reports, 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 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.Prior to use, always inspect suture needle for damage (i.E., worn, dull, bent or cracked).Do 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.H3 other text : device not yet received.

Event Description

This complaint was created due to the receipt of a mir report mhra reference number: (b)(4) received on 7jul23.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The report was found to be written against the c6360 spectrum ii suture hook, 45 degree right.The report states that on (b)(6) 2023 ¿during arthroscopic stabilization of shoulder, the end of a 45 degree suture hook snapped off whilst inside the patients joint space.The operating surgeon had to convert to an open procedure in order to retrieve the broken instrument¿.After further assessment it was found that there was no extended hospital stay for the patient.Patient's current status was reported as "outpatient".The procedure was completed with a delay of 30 minutes to an hour.This report is being raised on the basis of injury due to converting to an open procedure.

Event Description

This complaint was created due to the receipt of a mir report mhra reference number: (b)(4) received on 7jul2023.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The report was found to be written against the c6360 spectrum ii suture hook, 45 degree right.The report states that on (b)(6) 2023 ¿during arthroscopic stabilization of shoulder, the end of a 45 degree suture hook snapped off whilst inside the patients joint space.The operating surgeon had to convert to an open procedure in order to retrieve the broken instrument¿.After further assessment it was found that there was no extended hospital stay for the patient.Patient's current status was reported as "outpatient".The procedure was completed with a delay of 30 minutes to an hour.This report is being raised on the basis of injury due to converting to an open procedure.

Manufacturer Narrative

Update: reported event of ¿hook snapped off¿ is confirmed.The device was returned in unoriginal packaging; the lot number was verified on the device.Visual inspection of the returned used device found the hook broken off; the hook was not returned with the device.Manufacturer report: reported event of ¿hook snapped off¿ is confirmed.The device has not been returned to date, but photographic evidence has been provided.If the device is returned, at a later date, the investigation may be updated and reanalyzed.Root cause cannot be determined, however, based upon photos and the ifu; a possible cause of this event could be excessive force.(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.Prior to use, always inspect suture needle for damage (i.E., worn, dull, bent or cracked).Do 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 II SUTURE HOOK, DISPOSABLE, 45 DEGREE RIGHT, QTY 5
• Type of Device: 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: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 17360606
• MDR Text Key: 319389109
• Report Number: 1017294-2023-00068
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C6360
• Device Lot Number: 920648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic