MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. RICHARD-ALLAN / ASPEN SURGICAL PRODUCTS; DISPOSABLE SUTURE NEEDLE

Model Number 216706

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2016

Event Type  No Answer Provided  

Event Description

Avid medical is the manufacturer of a custom procedure tray that includes the following component: richard-allan® suture needle ½ circle tapered 1 mayo, vendor part # 216706 manufactured by aspen surgical products inc.Avid medical received a complaint on (b)(6) 2016 originated by(b)(6) stating that during the case, the suture needle broke.The complained suture needle was available for evaluation.Avid medical issued formal complaint #(b)(4) to the manufacturer aspen surgical concerning the needles breaking during surgery for item no.216706, manufacturer lot# 108419.No patient injury was reported.

• Brand Name: RICHARD-ALLAN / ASPEN SURGICAL PRODUCTS
• Type of Device: DISPOSABLE SUTURE NEEDLE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt drive se; caledonia MI 49316
• Manufacturer Contact: sharon moll ; 9000 westmont dr.; toano, VA 23168
• MDR Report Key: 6178467
• MDR Text Key: 62865443
• Report Number: 1047429-2016-00020
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: 216706
• Device Lot Number: 108419
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1