MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK 6 X 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202260
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an arthroscopy, it was noticed that the biosure was used out of date (expired).The patient outcome is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.It was determined the device did not contribute to the reported event.A complaint history review concluded this was an isolated event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was 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.Specifically, "do not use after the expiration date".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 review of the customer provided image found an orthopedic order form with the label of the device on it.The label is highlighted and the expiration date is also circled.The expiration is 26 jan 2021, and the order date on the form is (b)(6) 2021, which is past the expiation of the device.Data shows that products from our warehouse remain sterile after 20 years if the seals are intact.Regarding the 72202260, biosure pk 6 x 25mm, it had an expiration date of 26 jan 2021 and was implanted on (b)(6) 2021.Based on our data, it is highly likely that the product was sterile if the end-user¿s inspection of the packaging showed that the seals were intact, and it is not expected to have an adverse impact to the patient or the procedure.It is the responsibility of the end-user to confirm the expiration and integrity of the product/packaging prior to use.The impact to the patient beyond that which has already been reported is unknown.Therefore, no further clinical assessment is warranted at this time.The complaint was confirmed, and the root cause was associated with unintended use of the device.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: BIOSURE PK 6 X 25MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 12955256
• Report Number: 1219602-2021-02669
• Device Sequence Number: 14532349
• Product Code: MBI
• UDI-Device Identifier: 03596010621986
• UDI-Public: 03596010621986
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

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: 01/26/2021
• Device Model Number: 72202260
• Device Catalogue Number: 72202260
• Device Lot Number: 50584382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 02/25/2022
• Date Device Manufactured: 01/26/2016
• 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