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

Model Number SXPD2B405

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

To date a lot number has not been provided and therefore we are unable to perform a lot review to determine if there were any non-conformances reports with this issue.The needle is an ethicon component.No samples were returned for testing or review.There were no retained samples available for testing.Ethicon third party summary has not been received to date.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 or results from the third party analysis, 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

It was reported by the sales rep that during an orthopedic procedure the tip of the needle broke off and fell into the patient.Via xray it was located and then retrieved delaying the case.A new device was used to complete the case with no patient consequences.No device will be returned.

• Brand Name: STRATAFIX SUTURE
• Type of Device: 2CTX #2 PDO 36 X 36
• Manufacturer (Section D): SURGICAL SPECIALTIES; corredor tijuana rosarito 2000; #24702 b, ejido francisco vill; tijuana ; MX
• 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 02090
• MDR Report Key: 10684649
• MDR Text Key: 213454083
• Report Number: 3010692967-2020-00034
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K080985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2020,10/15/2020

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
• Device Operator: Health Professional
• Device Model Number: SXPD2B405
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2020
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention