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

Model Number	SXPL1B400
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A batch review of the finished good lot, labeling and components confirmed there were no quality issues noted throughout the incoming inspection, manufacturing, sterilization, in-process, or final inspection process.No similar complaints reported to date for ethicon or any other products manufactured by surgical specialties.The ifu for polypropylene is titled and states.Knotless tissue control device non-absorbable surgical suture material stratafix¿ spiral polypropylene device elicits a minimal acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the stratafix¿ spiral polypropylene device by fibrous connective tissue.Stratafix¿ spiral polypropylene device is not absorbed, nor is any significant change in tensile strength retention known to occur in vivo.The product has all the appropriate instructions and labeling both on the outer box label as well as the inner package label.The wrapping card is printed with only material type (ppn) and size (0).This is what the surgeon was referring to when he stated the information should match the label.The card is not large enough to print the entire description as printed on all labeling and ifu.The root cause was determined as user error.
Event or Problem Description
The following event was reported by our distributor: procedure/surgery name gastric bypass.Procedure/surgery date (b)(6) 2023.Describe event a stratafix non-absorbable was used in gastric bypass, anastomosis gastro-entero.This was a mistake, because it should be an absorbable.The user didn¿t see non-abs on the inner package, and therefore thought it was ok to use.Is this report related to a: single use device.Is this the first time that the device was being used? no.When did the device problem occur? while suturing gastro-entero anastomosis.Was the user trained? yes.What action was taken/required to manage the problem during the procedure? they needed to cut out the whole suture and place a new one.How long was the procedure prolonged as a result of the difficulties encountered with the device (minutes)? 30 minutes.No patient consequences.Has the surgeon or doctor provided a medical rationale that indicates the use of the product is in no way related to the reported event?: he would like to see more info on inner and outer package, or at least, the same info on inner package so mistakes can be avoided.

• Brand Name: STRATAFIX
• Common Device Name: SH-1 0 PPN 30CM
• 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: 16829863
• Report Number: 3010692967-2023-00016
• Device Sequence Number: 13935944
• Product Code: GAW
• UDI-Device Identifier: 10705031228122
• UDI-Public: (01)10705031228122(20)16(17)270831(10)C929HFO
• 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: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2023
• Report Date (Section F): 04/13/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: SXPL1B400
• Device Lot Number: C929HFO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• 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 Sex: Unknown