MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE R.L. DE C.V STRATAFIX; CT-1 0 PDO 30CM

Model Number	SXPD1B401
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/27/2024
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, in-process, or final inspection.The needle component is supplied by ethicon.A review of the broken needle will be performed by a 3rd party laboratory.No samples, or photographs of the actual device were provided for review.No third party evaluation report was received to date.If samples, photos or the report become available at a later time, they will be reviewed, and the results will be included in the file.A follow-up report will be submitted at that time.The suture breaking during use most likely resulted from the interaction of specific procedural related stress in contrast to the suture strength.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 (1/3) to one-half (1/2) of the distance from the swaged end to the point.¿ pdo suture material can change color, become brittle; break easily if exposed more than the recommended time for this type of material.Surgical specialties documents the exposure time throughout the inspection and manufacturing processes to prevent over-exposure prior to packaging the devices.Exposure time for this specific lot met the current criteria.A definitive root cause is difficult to determine without receiving sterile device(s) from the same finished good lot for testing/review, receiving the actual device(s) to examine under a microscope, receiving magnified photos of the actual suture device(s)/needles or receiving detailed information regarding shipping, storage and handling of the device(s), pre-operative preparation of the device, exposure time prior to use, procedure performed, types of tools used to grasp the needle, if the procedure was robotic what size trocar was used compared to the needle size on the device or the surgeon''s technique.
Event or Problem Description
The health authority reported to our distributor the suture was broken when the surgeon attempted to sew skin during a spinal procedure.Besides, the needle broke.The doctor replaced the suture with a new one and checked whether the broken suture was intact and whether it was left in the patient''s body.Additional detail of intervention or delay could not be obtained.

• Brand Name: STRATAFIX
• Common Device Name: CT-1 0 PDO 30CM
• 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; 247 station drive; suite ne1; westwood MA 02090
• Manufacturer Contact: ronald giannangelo ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 18913440
• Report Number: 3010692967-2024-00017
• Device Sequence Number: 12519258
• Product Code: NEW
• UDI-Device Identifier: 10705031227941
• UDI-Public: (01)10705031227941(20)12(17)280531(10)D629WOQ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2024

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 Model Number: SXPD1B401
• Device Lot Number: D629WOQ
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/27/2024
• Device Age: 8 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Other
• Patient Age: 51 YR
• Patient Sex: Male