MAUDE Adverse Event Report: CONMED SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT

Catalog Number	C6370
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device was discarded at the facility; therefore, an evaluation was unable to be performed.The complaint cannot be verified.A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture that would contribute to this issue.This is the only complaint against this lot.A two-year historical complaint review revealed 13 similar complaints have been received for the device family.(b)(4).To prevent the problem from recurring and to reduce the risk of potential patient injury, the instruction for use provide the following information.-avoid lateral stresses to the instrument or device function may be compromised.There is an increased risk of hook or needle breakage.This incident type will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported while using a spectrum suture hook, the hook broke inside the cannula.The broken piece was retrieved from the cannula and this malfunction caused a 2 minute surgical delay.The procedure was completed as intended with the use of an alternative device.No patient injury was reported.This report is raised on the basis of a reported device malfunction with potential for injury with recurrence.

• Brand Name: SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT
• Common Device Name: SUTURE HOOK
• Manufacturer (Section D): CONMED; 11311 concept blvd; largo FL 33773
• MDR Report Key: 7118607
• Report Number: 1017294-2017-00133
• Device Sequence Number: 13870429
• Product Code: LXH
• UDI-Device Identifier: 10845854031117
• UDI-Public: (01)10845854031117(11)170720(30)1(10)852413
• 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): 12/14/2017

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: C6370
• Device Lot Number: 852413
• 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: 11/16/2017
• Initial Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1