MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; RB-1 3-0 MONODERM 20CM

Model Number	SXMD1B402
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was not provided.So a batch review of the finished good lot and components could not be reviewed at this time.The needle is an ethicon device.The actual devices or magnified photos were not returned for review.If samples or photos become available at a later time, they will be reviewed and tested and the results will be included in the file.A follow-up report will be submitted at that time.A potential root cause for a needle detaching when slightly tugged during a procedure, could be that the suture was not fully inserted within the end of the needle during the manufacturing process.It¿s also possible, the device(s) are being grasped on or near the swaged end, damaging the suture, allowing it to break free from the needle component.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¿.Without reviewing the finished good, lot number to review manufacturing records and retained samples, receiving the actual reported device for review, receiving magnified photos of the actual device, or receiving detailed information regarding the preoperative preparation of the device, tools utilized to grasp the device, details of the procedure performed, or the surgeon¿s technique.A definitive root cause cannot be determined at this time.
Event or Problem Description
It was reported by the health authority to our distributor, at 10:30 am it was reported, that the problem of pulling off suture needle happened when the surgeon attempted to sew anterior cervical fascia.Resulting in needle loss and re suturing, delaying the surgical time.After finding the broken needle, changed another one to complete the surgery.
Additional Manufacturer Narrative
Corrected the device and patient codes in section f.
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 component.No retained samples were available for review.No samples or third party report was provided.A definitive root cause cannot be determined at this time.

• Brand Name: STRATAFIX
• Common Device Name: RB-1 3-0 MONODERM 20CM
• Manufacturer (Section D): SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V.; corredor tijuana rosarito 2000; 24702 b, ejido francisco villa; tijuana 22245 ; MX 22245
• 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 22245 ; MX 22245
• MDR Report Key: 16825567
• Report Number: 3010692967-2023-00017
• Device Sequence Number: 12439719
• Product Code: GAM
• UDI-Device Identifier: 10705031228115
• UDI-Public: (01)10705031228115(20)12(17)270228(10)C324UXO
• 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,Followup,Followup
• Report Date (Section B): 06/22/2023
• Report Date (Section F): 04/24/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SXMD1B402
• Device Lot Number: C324UXO
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/12/2023
• Device Age: 15 MO
• Date Report to Manufacturer: 04/24/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 04/27/2023; 06/22/2023
• 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: Other; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female