MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE R.L. DE C.V STRATAFIX; SH 2-0 MONODERM 20CM

Model Number	SXMD1B405
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records for the reported finished good lot and raw material components identified no quality issues during the incoming, manufacturing, in-process, or final inspection processes.No additional complaints have been received for this lot.Sterile samples from the reported lot were not returned for visual review and testing.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.Without reviewing the actual reported device(s), receiving magnified photos of the actual devices, or receiving detailed information regarding the method utilized to remove the device from the packaging, preoperative preparation of the device, tools utilized to grasp the devices, details of the procedure performed, or the surgeon¿s technique, a definitive root cause cannot be determined at this time.
Event or Problem Description
Our affiliate reported the needle detachment from the suture and fell into the body cavity.

• Brand Name: STRATAFIX
• Common Device Name: SH 2-0 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 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; 247 station drive; suite ne1; westwood
• Manufacturer Contact: ronald giannangelo ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana
• MDR Report Key: 20340302
• Report Number: 3010692967-2024-00082
• Device Sequence Number: 8023792
• Product Code: GAM
• UDI-Device Identifier: 10705031228061
• UDI-Public: (01)10705031228061(20)12(17)280930(10)DA20HAVE
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2024

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: SXMD1B405
• Device Lot Number: DA20HAV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2023
• 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: 67 YR
• Patient Sex: Female