MAUDE Adverse Event Report: CONMED SPECTRUM AUTOPASS NEEDLE

Catalog Number	SMI-02N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device was not reported to be returned to conmed for evaluation.This alleged device malfunction cannot be verified.(b)(4).A risk analysis was performed and the risk was deemed acceptable.The instructions for use advise the user of the following.Device is not to be used on the bone or similar hard tissue.Weather used arthroscopically or in open surgery, the suture passer must be used under direct visualization.Avoid lateral stress on the needle as this could cause device breakage.If the suture passer needle kinks during use, immediately discontinue use and discard.There is an increased risk of needle breakage and unintentional patient injury may result.This incident type will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
A conmed affiliate reported on behalf of a customer that the tip of the smi-02n needle broke off during pre-op testing prior to a rotator cuff procedure.This alleged malfunction did not cause harm to the patient or a surgical delay as it was found before the procedure began.To date, additional information regarding the patient and event have not been provided.This report is raised on the basis of a reported device malfunction with potential for patient injury with recurrence.
Additional Manufacturer Narrative
Correction of initial reporter and facility name.Correction of awareness date from 16nov2017 to 14nov2017.Spelling correction."weather" should be "whether".

• Brand Name: SPECTRUM AUTOPASS NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): CONMED; 11311 concept blvd; largo FL 33773
• MDR Report Key: 7084681
• Report Number: 1017294-2017-00131
• Device Sequence Number: 1495492
• Product Code: LXH
• UDI-Device Identifier: 20845854045753
• UDI-Public: (01)20845854045753(17)220126(10)40353
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2017

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 Expiration Date: 01/26/2022
• Device Catalogue Number: SMI-02N
• Device Lot Number: 40353
• 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
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1