MAUDE Adverse Event Report: CONMED LARGO 3.4MM X 130MM SUTURE HOOK, STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	97.10015
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, (b)(6), 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.
Additional Manufacturer Narrative
Reported event of ¿tip snapped off and fell into the patient and the fragments were retrieved¿ is confirmed.Visual examination of the returned used product item 97.10015 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.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.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) 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.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: 3.4MM X 130MM SUTURE HOOK, STRAIGHT
• 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: 17630358
• Report Number: 1017294-2023-00078
• Device Sequence Number: 12380436
• Product Code: LXH
• UDI-Device Identifier: 10845854018972
• UDI-Public: (01)10845854018972(11)220606(10)1248273
• 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: 97.10015
• Device Lot Number: 1248273
• 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: 06/06/2022
• 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: (B)(6), CRESCENT HOOK 3MM X 15MM.; (B)(6), CRESCENT HOOK 3MM X 15MM.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic