MAUDE Adverse Event Report: SURGICAL SPECIALTIES STRATAFIX; STRATAFIX MONODERM SUTURE

Device Problem Break (1069)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

To date the sample has not been received.The lot number has not been provided therefore making a dhr review impossible at this time.Without reviewing the actual sample, an exact root cause for the non-conformance reported cannot be determined at this time.A possible cause could be bending, fracturing, breaking of a needle can occur when needles are gripped with a needle holder/forceps at the swaged area and/or near the tip of the device.The stress at the gripped area may exceed the maximum stress of the material resulting in bending and/or failure (broken needle).The stress on the attachment section is greatly reduced when the needle is held in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point as indicated in the ifu for this product.

Event Description

It is being reported by our affiliate the needle broke off underneath the skin.X-rays were used to locate and retrieve the broken piece and there no patient consequences reported.

• Brand Name: STRATAFIX
• Type of Device: STRATAFIX MONODERM SUTURE
• Manufacturer (Section D): SURGICAL SPECIALTIES; rd 495 montana industrial park; aguadila PR 00605
• Manufacturer (Section G): SURGICAL SPECIALTIES; rd 495 montana industrial park; aquadila PR 00605
• Manufacturer Contact: ronald giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 8239711
• MDR Text Key: 132794374
• Report Number: 3010692967-2019-00001
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 12/17/2018
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/31/2018
• Date Manufacturer Received: 12/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1