MAUDE Adverse Event Report: SURGICAL SPECIALTIES STRATAFIX SUTURE; 2SH -0- PDO 14 X 14 13MM LEADER

Model Number SXPD2B414

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 05/21/2021

Event Type  malfunction  

Event Description

It was reported that after using the needle in an unknown surgery, it was found that the tip of the needle was missing.No details of intervention was provided.The surgery was completed with further incident or injury.No additional information was provided.

Manufacturer Narrative

A batch review of the reported lot indicated there were no non-conformance reports issued for the finished good lot.The product from this finished good lot and all of the components met surgical specialties requirements throughout the incoming, manufacturing and the final inspection processes.The needle is an ethicon supplied component.No samples or evaluation reports were received to date.There were no retained samples available for testing.If samples or the report become available at a later time, they will be reviewed and the results will be included in the file.To date, a third party evaluation report has not been received from ethicon.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, receiving 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.

Manufacturer Narrative

A typing error was found in the narrative of the initial medwatch report which indicated the surgery was completed with further incident.The purpose of the report is to correct the narrative to indicate the surgery was completed with no further incident.

Event Description

It was reported that after using the needle in an unknown surgery, it was found that the tip of the needle was missing.No details of the intervention were provided.The surgery was completed with no further incident or injury.No additional information was provided.

• Brand Name: STRATAFIX SUTURE
• Type of Device: 2SH -0- PDO 14 X 14 13MM LEADER
• Manufacturer (Section D): SURGICAL SPECIALTIES; corredor tijuana rosarito 2000; 24702 b, ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 11977679
• MDR Text Key: 280459489
• Report Number: 3010692967-2021-00021
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/31/2021,06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: SXPD2B414
• Device Lot Number: MDWL180
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/21/2021
• Device Age: 3 YR
• Date Report to Manufacturer: 05/31/2021
• Date Manufacturer Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other