MAUDE Adverse Event Report: CONMED CORPORATION SPECTRUM AUTOPASS NEEDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	SMI-02N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used/damaged spectrum autopass needle is not expected for evaluation as it was discarded at the user facility.Without the involved device an evaluation could not be performed and the root cause of the alleged "needle tip breakage" could not be determined.There has been one other complaint for this item and lot number combination received from this same facility.A 2-year review of complaint history for this product family and failure mode shows there have been a total of (b)(4) reports of tip breakage involving (b)(4) needles.During this same time frame, approximately (b)(4) units have been sold worldwide, making the rate of occurrence for this failure mode (b)(4).This failure mode is addressed in the dfmea, and the safety risk has been found to be acceptable.To date, there have been no patient long term adverse effects resulting from this type of incident.The needle shaft and blade are made of (b)(4) super elastic nitinol.A material routinely used in the manufacture of medical instruments with a long history of safe and effective clinical use.Nitinol is used in vascular stents, valve patches and orthodontic devices.To reduce the risk of needle breakage and patient injury, the information for use (ifu) provides the user with the following warnings: avoid lateral stresses to the instrument or device function may be compromised.Do not use if parts are broken, cracked or worn, or device function may be compromised.Whether used arthroscopically or in open surgery the suture passer must be used under direct visualization.If tissue is excessively thick or rolled and suture passer jaws do not close far enough there is a chance of suture passer needle missing the window of the suture retrieval mechanism.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.Do not use disposable suture passer needle for more than one (1) procedure.Reuse could cause fatigue and/ or breakage of the needle, which may cause possible patient injury.
Event or Problem Description
The sales representative reported that while attending a shoulder arthroscopy procedure, the spectrum autopass suture passer and the spectrum autopass needle were used to pass hifi suture.While passing the suture the tip of the needle broke off into the patient's shoulder.The tip was retrieved using a grasper.The procedure was completed with a 1-minute delay reported and no patient injury or any further surgical complication.This report is filed on the basis of potential for patient injury with recurrence.

• Brand Name: SPECTRUM AUTOPASS NEEDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6375951
• Report Number: 1017294-2017-00021
• Device Sequence Number: 1081049
• Product Code: LXH
• UDI-Device Identifier: 20845854045753
• UDI-Public: (01)20845854045753(17)211128(10)40142
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/03/2017

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: 11/28/2021
• Device Catalogue Number: SMI-02N
• Device Lot Number: 40142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2017
• Initial Report FDA Received Date: 03/03/2017
• 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: SPECTRUM AUTOPASS SUTURE PASSER