MAUDE Adverse Event Report: CONMED LARGO CRESCENT HOOK 3MM X 15MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	C8740
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
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
Conmed japan reported on behalf of their customer that the devices, c8740, crescent hook 3mm x 15mm and the 97.10015, 3.4mm x 130mm suture hook, straight were being used on (b)(6) 2023 during a bankart repair procedure and ¿it was reported that two hook points of suture hook i were damaged.It is confirmed that it is damaged because it was pulled out by force.¿ there was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.The procedure was completed with ¿about a 5 minute delay¿.After further assessment it was discovered that for both devices the tip snapped off and fell into the patient and the fragments were retrieved.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
Conmed japan reported on behalf of their customer that the devices, c8740, crescent hook 3mm x 15mm and the 97.10015, 3.4mm x 130mm suture hook, straight were being used on 20jul23 during a bankart repair procedure and ¿it was reported that two hook points of suture hook i were damaged.It is confirmed that it is damaged because it was pulled out by force.¿ there was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.The procedure was completed with ¿about a 5 minute delay¿.After further assessment it was discovered that for both devices the tip snapped off and fell into the patient and the fragments were retrieved.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Visual examination of the returned used product item c8740 confirms the reported problem and found the suture hook needle broken off at the shaft.Suture hook needle was broken loose at the laser weld.Lot number is unable to be verified, conmed shipping label was not returned.Root cause cannot be determined, however, based upon photos and ifu; a possible cause of this event could be excessive force.Although this is a reusable device, it is not serviceable.Therefore, a service history is not available for review.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 exceed five (5) procedures per limited reuse suture hook.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: CRESCENT HOOK 3MM X 15MM
• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 17630360
• Report Number: 1017294-2023-00077
• Device Sequence Number: 15071290
• Product Code: LXH
• UDI-Device Identifier: 10845854034422
• UDI-Public: (01)10845854034422(11)210601(10)1170142
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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 Catalogue Number: C8740
• Device Lot Number: 1170142
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 97.10015, 3.4MM X 130MM SUTURE HOOK, STRAIGHT; 97.10015, 3.4MM X 130MM SUTURE HOOK, STRAIGHT
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic