MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 6MM X 25MM; SCREW, FIXATION, BONE

Catalog Number	72201769
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	08/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that the patient underwent patellofemoral orthopedic surgery on (b)(6) 2023 with screws for intraoperative fixation of the ligaments including biosure screw; there was secretion from the medial knee wound 4 weeks postoperatively, and the wound did not improve significantly after dressing changes at the local hospital.On (b)(6) the patient underwent wound debridement with vsd drainage, and anti-infection treatment was also given, and the wound is now healing well.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records and sterilization 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 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 clinical review states that there were no clinical factors found which would have contributed to the reported event.However, it was reported that the incident was not related to the implant.The implant was not removed as a result.It was reported that the patient has recovered.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.
Event or Problem Description
It was reported that the patient underwent patellofemoral orthopedic surgery on (b)(6) 2023 with screws for intraoperative fixation of the ligaments including biosure screw; there was secretion from the medial knee wound 4 weeks postoperatively, and the wound did not improve significantly after dressing changes at the local hospital.On (b)(6) 2023, the patient underwent wound debridement with vsd drainage, and anti-infection treatment was also given, and the wound is now healing well.No further complications were reported.

• Brand Name: BIOSURE HA 6MM X 25MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 17777657
• Report Number: 1219602-2023-01805
• Device Sequence Number: 6669054
• Product Code: HWC
• UDI-Device Identifier: 03596010611659
• UDI-Public: 03596010611659
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080358
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2023

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 Catalogue Number: 72201769
• Device Lot Number: 50993427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 11/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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 Age: 18 YR
• Patient Sex: Female