MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK 7 X 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202263

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/05/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during the set up for an arthroscopic procedure, the packages of the 'biosure' screws were already open and sterility was affected.The procedure was successfully completed with no surgical delay using a back-up device.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).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.It was determined 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.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 instruction found that each device is inspected for integrity and particulate before being loaded into its carrier and pouch.Once the device is inserted into the pouch, it is then loaded into the sealer and the pouch is sealed.A review of the customer provided images finds information confirming the complaint device.One image shows the packaging open, there is debris indicating that a seal was present on the packaging.The complaint was confirmed, and the root cause could not be established since the device was not returned for evaluation.Factors that could have contributed to the reported event include inadvertent excessive force to the package.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 7 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: 14461571
• MDR Text Key: 292346316
• Report Number: 1219602-2022-00763
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010621610
• UDI-Public: 03596010621610
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202263
• Device Catalogue Number: 72202263
• Device Lot Number: 50953956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• 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