MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCU-PASS STR SHUTTLE 45 DEG UP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7210425
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during meniscus repair procedure, when the out of box was opened, the sterilization pack seal of the accu-pass 45-degree did not close from the first.The device was used on the patient.A backup device was available to complete the procedure with no delay or patient injuries.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h2: additional information: h6: health effect - clinical and impact code.H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an analysis of the customer provided images found a device refencing a part number 7210425 and lot 50745677.Matching the reported one.The black monofilament seems to be all around the pouch.The pouch seem to be open, from the top and there's a hole from the left side.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the packaging procedure, found that the operator should place the device inside the pouch and inspect seal, set up verification in the boxing area and then, the sealed pouch should be placed with the ifu and patient label inside the carton before closing it.The root cause of the reported event could not be determined since findings can not lead to a clear cause of the reported event factors that could have contributed to the reported event include rough handling during transport or storage, or exposure of the packaging to excessive heat.The investigation findings were escalated to the manufacturing team, and it was determined that this type of punctured would suggest rough handling of the shipment and not a root cause that would impact other product lots.No containment or corrective actions are required at this time.
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an analysis of the customer provided images found a device refencing a part number 7210425 and lot 50745677.Matching the reported one.The black monofilament seems to be all around the pouch.The pouch seem to be open, from the top and there's a hole from the left side.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the packaging procedure, found that the operator should place the device inside the pouch and inspect seal, set up verification in the boxing area and then, the sealed pouch should be placed with the ifu and patient label inside the carton before closing it.The root cause of the reported event could not be determined since findings can not lead to a clear cause of the reported event.Factors that could have contributed to the reported event include rough handling during transport or storage, or exposure of the packaging to excessive heat.The investigation findings were escalated to the manufacturing team, and it was determined that this type of punctured would suggest rough handling of the shipment and not a root cause that would impact other product lots.No containment or corrective actions are required at this time.

• Brand Name: ACCU-PASS STR SHUTTLE 45 DEG UP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10865731
• Report Number: 1219602-2020-01867
• Device Sequence Number: 2799488
• Product Code: LXH
• UDI-Device Identifier: 03596010534460
• UDI-Public: 03596010534460
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2021
• Device Model Number: 7210425
• Device Catalogue Number: 7210425
• Device Lot Number: 50745677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 06/14/2024; 07/16/2024
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 06/17/2024; 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2018
• 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
• Patient Sex: Unknown