MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX; 2CTX #2 PDO 36 X 36

Model Number SXPD2B405

Device Problems Component Missing (2306); Noise, Audible (3273)

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

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records for the finished good lot and the raw material components identified no quality issues during the incoming, manufacturing, in-process or final inspection processes.The needle component is supplied by ethicon.No samples were returned for testing or review.No retained samples are available for testing/review.If samples become available at a later time the devices will be evaluated and the results will be included in the file and follow-up will be submitted.The bending, fracturing, breaking of a needle can occur when needles are gripped with a needle holder, forceps, surgical instrument on or near the swaged area or near the tip of the device, when excessive force is applied, when the device(s) are used in applications involving tortuous tissue or with a needle tip design that may not be appropriate for the specific tissue or procedure.Without reviewing the actual broken needle, receiving magnified photos of the broken device, testing sterile devices from the same finished good lot or receiving details regarding the tools utilized to grasp the needle component, procedure performed or the surgeon¿s technique a definitive root cause cannot be determined at this time.

Event Description

The end user is reporting during quadriceps tendon repair, the needle was being grasped by the needle holder.The surgical assistant heard a pop and the distal tip was missing from the device.X-rays confirmed the tip was not retained inside the patient and the wound was closed.

• Brand Name: STRATAFIX
• Type of Device: 2CTX #2 PDO 36 X 36
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702 b, ejido francisco vill; tijuana 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: ronald giannangelo ; 247 station drive; suite ne1; westwood, MA 19608
• MDR Report Key: 9481199
• MDR Text Key: 207426595
• Report Number: 3010692967-2019-00043
• Device Sequence Number: 1
• Product Code: NEW
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPD2B405
• Device Lot Number: AAEL933
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 12/09/2019
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2019
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention