MAUDE Adverse Event Report: SURGICAL SPECIALTIES STRATAFIX SUTURE; 2MH #1 PDO 24 X 24

Model Number	SXPD2B410
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A batch review of the reported lot indicates there were no non-conformances reports issued for the finished goods lot.The product from this finished goods 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.
Event or Problem Description
It was reported that the needle broke when sewing during the surgery a laparoscopic myomectomy.It was converted to a laparotomy surgery.Changed another one to complete the surgery.No additional information could be provided.

• Brand Name: STRATAFIX SUTURE
• Common Device Name: 2MH #1 PDO 24 X 24
• Manufacturer (Section D): SURGICAL SPECIALTIES; corredor tijuana rosarito 2000; #24702 b, ejido francisco vill; tijuana 22235 ; MX 22235
• MDR Report Key: 10800433
• Report Number: 3010692967-2020-00037
• Device Sequence Number: 3570095
• Product Code: NEW
• UDI-Device Identifier: 20705031207865
• UDI-Public: (01)20705031207865(20)36(17)211231(10)AAAS279
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: SXPD2B410
• Device Lot Number: AAAS279
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 YR
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention