MAUDE Adverse Event Report: CONMED CORPORATION SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT; EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDIC

Catalog Number	C6370
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was reported as being discarded at the user facility and will not be returned for evaluation by the manufacturer.The manufacturing document from the device history record have been reviewed with special attention to the manufacturing and inspection of the device.The device 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: if the hook or needle bend 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 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 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.
Event or Problem Description
It was reported by the sales representative on behalf of the facility that during a surgical event on (b)(6) 2018 the c6370, spectrum ii suture hook, medium crescent, broke while inside the cannula.None of the device components fell into the surgical site and no medical intervention was required for the patient.The device was then thrown away after removal from the cannula.There was no delay or cancellation of the surgery.This report is raised on the basis of device malfunction with a potential for injury with occurrence.

• Brand Name: SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT
• Common Device Name: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDIC
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773
• MDR Report Key: 7374806
• Report Number: 1017294-2018-00044
• Device Sequence Number: 993256
• Product Code: LXG
• UDI-Device Identifier: 10845854031117
• UDI-Public: (01)10845854031117(11)170918(10)863196
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

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: Physician
• Device Catalogue Number: C6370
• Device Lot Number: 863196
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1