MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX; SFX SPI PGAPCL UNI UD 20CM 2-0 S/A RB-1

Model Number	SXMD1B403
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Wrong needle type.It was reported that the needle type was found to be inconsistent with the actual specification.It was a cutting needle rather than a taper point needle when the package was opened for an unknown surgery.Changed to another one to complete the surgery.There is no report of patient injury.Not used in the procedure.Another device was readily available.
Additional Manufacturer Narrative
Reference (b)(4) the problem was not identified following the investigation, review of the device history record, review of photos or actual sample review.An additional complaint was received (b)(4), samples were returned and the problem was identified on (b)(6) 2022.An hhae was completed by a medical expert.The final determination little to no safety or risk to the population.The devices were found with a cutting edged tip rather than a taper point tip.In fragile tissues, such as mucosa, there is a chance of the needle being too aggressive and allowing a tear through the tissue being handled.Most clinicians would readily observe the type of needle being utilized.It's highly unlikely that a clinician would unknowingly use a cutting rather than a tapered needle.No particular segment of the population is at a greater risk.There are no significant public health impacts possible to users of this suture/needle device.There are no significant health risks associated with this event.The choice of needle is directed by the clinician.If an inappropriate needle is offered to the surgeon/clinician, the surgeon/clinician can simply request and obtain the correct device.A capa was initiated to investigate this nonconforming condition.A follow-up report will be submitted with the final conclusion/root cause analysis/corrective action.A recall was initiated by ethicon.
Additional Manufacturer Narrative
Capa (b)(4) was initiated to determine the root cause(s) and to implement corrective action(s).The main cause was determined to be manufacturing related/employee error.It was identified there were gaps in some of the procedures and processes.The employees placed the shop packet with the wrong order; the employee did not review information as part of the inspection.Changes to processes, updates to procedures and re-training of employees is in-process.The action plan completion date is 6/3/2022.

• Brand Name: STRATAFIX
• Common Device Name: SFX SPI PGAPCL UNI UD 20CM 2-0 S/A RB-1
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; 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: 13801309
• Report Number: 3010692967-2022-00008
• Device Sequence Number: 17403721
• Product Code: GAM
• UDI-Device Identifier: 10705031228054
• UDI-Public: (01)10705031228054(20)12(17)260331(10)AAHM529
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K072028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022
• Report Date (Section F): 01/18/2022

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 Expiration Date: 04/07/2026
• Device Model Number: SXMD1B403
• Device Lot Number: AAHM529
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/21/2021
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2022
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown