MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX; STRAFIX PDO

Model Number SXPD2B400

Device Problem Break (1069)

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

Event Date 12/31/2018

Event Type  Injury  

Manufacturer Narrative

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.The needle itself is from supplied by an outside supplier.A review of the device history records for the finished good lot, did not identify any quality issues during the incoming, manufacturing, in-process or final inspection processes.There have been no lots released for distribution which failed to meet any of the product specifications or current acceptance criteria.

Event Description

It was reported that needle tip broke during laparoscopic excavation.Searched for the broken piece with a c-arm and flush with saline.It was not found in patient body.Changed another one to complete.

• Brand Name: STRATAFIX
• Type of Device: STRAFIX PDO
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; rd. 495 montana industrial pk; aguadilla PR 00605
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; rd 495 montana indusrial park; aguadilla PR 00605
• Manufacturer Contact: ronald giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 8499429
• MDR Text Key: 141462342
• Report Number: 3010692967-2019-00012
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: SXPD2B400
• Device Lot Number: MDVH410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 12/31/2018
• Device Age: 2 YR
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Patient Sequence Number: 1
• Patient Outcome(s): Other