MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; 2FS-2 2-0 UNDYD MONODERM 30X30

Model Number	SXMD2B408
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The barbs on the opposite side of the transition point would not catch in the subdermal layers and the suture would slide past on to the other side.The pa and physician reported, at least in one case, that a patient whom they were closing on had one of these sutures used.The patient then returned to clinic complaining of bleeding from the healing incision site.They did not report any infections or other worse symptoms.The providers were able to use suture to close the wound in the clinic itself and did not state that this issue was ongoing.Exact lot numbers affected could not be determined.
Additional Manufacturer Narrative
A possible second lot involved in the procedure, lot #: b929mmm, manufacture date: 09-30-2021.Bar code: (b)(4).A batch review of the reported lots indicated there were no non-conformances issued for the finished good lots.The product from the lots and all of the components met surgical specialties requirements throughout the incoming inspection, manufacturing, in-process and the final inspection processes.Samples have not been returned for review and/or analysis.There were no retained samples to evaluate.If samples or photos become available at a later time, they will be reviewed and the results will be included in a follow-up report.Without receiving sterile samples to review/test, receiving magnified photos of the devices and/or incision or receiving details regarding the method utilized to remove the device from the packaging, pre-operative preparation of the device, procedure performed, the method utilized to secure the device in the tissue, the surgeon¿s technique, patient¿s pre-existing health conditions/condition of tissue utilized to secure the device, post-operative instructions or events that may have occurred and/or contributed to the report of post-op bleeding, a definitive root cause cannot be determined at this time.Adverse effects associated with the use of this device may include, wound dehiscence, failure to provide adequate wound support in closure of the site where expansion, stretching or distension occur, failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from condition which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation which skin sutures are left in place for greater than 7 days, suture extrusion and delayed absorption in tissue with poor blood supply, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs and transitory local infection at the wound site.Infections, erythema, foreign body reactions, transient inflammatory reactions and in rare instances dehiscence are typical or foreseeable risks associated with any suture and hence are also potential complications associated with the barbed suture device.
Additional Manufacturer Narrative
Lot number: b929mmm.Sixty-one (61) samples from lot b929mmm were returned for review.Using an aql of 0.65, twenty of the samples were evaluated.No defects or abnormalities were observed; barbs were present on all the devices.The devices met all specifications including the requirements for angle, depth and placement of the barbs.Lot number: b802adt sixty (69) samples from lot b802adt were returned for review.Using an aql of 0.65, twenty of the samples were evaluated.One sample from the lot b802adt did not meet the current specification.Gaps without barbs were observed along the suture strand.The most probable root cause was confirmed as manufacturing related.It is possible a damaged tool was utilized during the set-up process of lot b802adt.The following corrective and preventive actions will be implemented to prevent this type of failure.1.All tooling will be reviewed to ensure they are in good condition.Completed: 01/17/22.2.The manufacturing procedure will be updated to include the inspection of the tools and an improved set-up process of the barbing machine.Proposed date of completion: 5/22/2022.
Event or Problem Description
Additional information: i spoke with multiple physician assistants who work with dr.(b)(6).He is the provider who uses this code of suture and experienced the problem repeatedly.The pas reported the issues severity with some differing degree of frustration however the common message was consistent with my initial report.The barbs on the opposite side of the transition point would not catch in the subdermal layers and the suture would slide past on to the other side.Clinical ad-hoc information the pa and physician reported, at least in one case, that a patient whom they were closing on had one of these sutures used.The patient then returned to clinic complaining of bleeding from the healing incision site.They did not report any infections or other worse symptoms that occurred; however, this level of product failure was unacceptable.There were two lot numbers on the same code of suture which the customer experienced issues with: b802adt and b929mmm.It was unreasonable to determine exactly which boxes were ones containing failed suture and those boxes remaining on the self with those same lot numbers could have more.Impacted product additional information - there were two lot numbers on the same code of suture which the customer experienced issues with: b802adt and b929mmm.It was unreasonable to determine exactly which boxes were ones containing failed suture and those boxes remaining on the self with those same lot numbers could have more.We deemed it prudent to offer no cost replacements to ensure a continued relationship.

• Brand Name: STRATAFIX
• Common Device Name: 2FS-2 2-0 UNDYD MONODERM 30X30
• 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 jauregui giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 12968470
• Report Number: 3010692967-2021-00055
• Device Sequence Number: 4331826
• Product Code: GAM
• UDI-Device Identifier: 20705031208114
• UDI-Public: (01)20705031208114(20)16(17)260731(10)B802ADT
• 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: Other,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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 Expiration Date: 07/31/2026
• Device Model Number: SXMD2B408
• Device Lot Number: B802ADT
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/02/2021
• Device Age: 4 MO
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• 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; Other
• Patient Sex: Unknown