MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACUFEX ACCESS ADV POS KIT; COMPONENT, TRACTION, NON-INVASIVE

Model Number	72205104
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that supply chain identified the acufex access advanced positioning kit that was not processed in the standard manner; compromising the sterility of the devices contained in the batch.At this time it is unknown if the device was used on the procedure.
Additional Manufacturer Narrative
B5: it was internally identified that non-sterile acufex access advanced positioning kit was shipped to the global distribution center instead of the sterilizer and therefore did not undergo the applicable sterilization process.This has been reported under 21 cfr 803 as a remedial action was initiated to address this issue.No complaints related to sterility or infection associated with this issue.D4: the following are the lot numbers impacted: 50971615, 50971617, and 50967788.H4: device manufacture date for each of the three lots that are impacted: 12 oct 2021 (lots 50971615 and 50971617) and 20 sep 2021 (lot 50967788).H9: reference number in section h9 of initial report is smith+nephew internal reference number specific to this remedial action.G2: user facility choice was inadvertently selected in initial report.Additionally, corrected information can be found in the following sections: d4, e2, h7, and h10.
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the device and the reported event.The complaint was confirmed and the root cause was associated with a fault during the manufacturing process.A review of the device records found a non conformance associated with the reported lots.A complaint history review found no similar reported events.A review of the manufacturing process found updates to standard practices, providing additional clarification for identification and shipment of sterilized product as a result of escalation actions related to this event.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A corrective action was implemented to mitigate future recurrence of the reported event and a field action was initiated to recall the product.Correction in h9.

• Brand Name: ACUFEX ACCESS ADV POS KIT
• Common Device Name: COMPONENT, TRACTION, NON-INVASIVE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13087731
• Report Number: 1643264-2021-02493
• Device Sequence Number: 5387073
• Product Code: KQZ
• UDI-Device Identifier: 00885556714126
• UDI-Public: 00885556714126
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2022

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 Model Number: 72205104
• Device Catalogue Number: 72205104
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 09/26/2022; 09/26/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 12/28/2021; 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0635-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown