MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; 2CT-1 #2 PDO 24 X 24

Model Number	SXPD2B402
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A batch review of the finished good lot and components confirmed there were no quality issues noted throughout the incoming inspection, manufacturing, sterilization, in-process, or final inspection process.The needle is an ethicon supplied component.The exact device was not returned for review.Samples from the same lot were not available for review.The third party evaluation report has not been received to date.If samples or the report become available at a later date, the samples or information will be reviewed and added to the file and a follow-up report will be filed.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.The ¿precautions¿ section in the ifu for the device states, ¿care should be taken to avoid damage when handling.Avoid crushing or crimping the suture material with surgical instruments such as needle holders and forceps.To avoid damaging needle points and swage areas, grasp the needle in an area one-third to one-half of the distance from the swaged end to the point¿.Without receiving ethicon¿s third party analysis, testing sterile devices from the same finished good lot, reviewing magnified photos of the broken device or receiving details regarding the tools utilized to grasp the needle component/size of trocar utilized, procedure performed or the surgeon¿s technique a definitive root cause cannot be determined at this time.
Event or Problem Description
Breakage needle.It was initially reported (b)(6) 2022 that the needle broke when sewing during myomectomy procedure at the second stitch.Changed to another one to complete the surgery.There is no report of patient injury.Additional information was later received (b)(6) 2022 indicating intervention.It was reported that the needle had fallen into the body and was retrieved with a needle holder; no injury or further incident reported.

• Brand Name: STRATAFIX
• Common Device Name: 2CT-1 #2 PDO 24 X 24
• Manufacturer (Section D): SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V.; corredor tijuana rosarito 2000; 24702 b, ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: luis giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 14525256
• Report Number: 3010692967-2022-00017
• Device Sequence Number: 11969996
• Product Code: NEW
• UDI-Device Identifier: 10705031207882
• UDI-Public: (01)10705031207882(20)12(17)260131(10)AAHH278
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2022
• Report Date (Section F): 05/17/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: SXPD2B402
• Device Lot Number: AAHH278
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/07/2022
• Device Age: 14 MO
• Date Report to Manufacturer: 05/17/2022
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown