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

Model Number	C6361
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation and no photographic evidence was provided therefore the 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.(b)(4).Per the instructions for use, the user is advised the following: avoid lateral stresses to the instrument 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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of the customer that the device, c6361 spectrum ii suture hook, 45 degree left was being used on (b)(6) 2022 and ¿the device broke during surgery.¿.There was no impact or injury to the patient.There was no report of medical/surgical intervention or prolonged hospitalization.The procedure was completed with an alternate same device and there was no delay to the procedure.After further assessment it was found the device did fragment and fall into the patient.The fragment was retrieved with a grasper.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: SPECTRUM II SUTURE HOOK, 45 DEGREE LEFT
• 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: 15940182
• Report Number: 1017294-2022-00111
• Device Sequence Number: 6347083
• Product Code: LXH
• UDI-Device Identifier: 10845854018668
• UDI-Public: (01)10845854018668(11)190102(10)986862
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2022

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: C6361
• Device Catalogue Number: C6361
• Device Lot Number: 986862
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2019
• 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
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic