MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK 8 X 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202267

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2022

Event Type  Injury  

Event Description

It was reported that during a repair of the anterior cruciate ligament, the outer package of the biosure anchor was found opened and there was no barcode and instructions for use.As the product was a disposable product, the surgeon immediately expressed doubts and did not open it.The procedure was successfully completed using a backup device, and a delay of 40 minutes was reported.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H10: 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 no way to determine if the device contributed to the reported event.A complaint history review found no similar reported events.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.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 packaging instructions found that each device is inspected and sealed prior to the operator placing the ifu, patient label and pouched product into product carton.It is required to ensure ifu is placed on the tyvek side of the pouch.Per e-mail communication, the product was found open and was not used on the patient, a back-up device was used.It was also communicated that the patient was not harmed due to the extended surgical time, the patient is fine and has been discharged.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was not confirmed.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device packaging or rough handling of the package causing the carton to open.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 8 X 25MM
• Type of Device: 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: 14722523
• MDR Text Key: 294251278
• Report Number: 1219602-2022-00879
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010621627
• UDI-Public: 03596010621627
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K083635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2023
• Device Model Number: 72202267
• Device Catalogue Number: 72202267
• Device Lot Number: 50728877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2022
• Date Device Manufactured: 04/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Sex: Male