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

Catalog Number	72204399
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an arthroscopy, when the biosure screw was inserted, it split, leaving 1 cm inside and the rest outside the femoral tunnel.An attempt was made to remove the broken piece, however, it was impossible, it was the decided to leave it inside the patient, since by forcefully removing it, the graft could be damaged.Surgery was completed by changing the surgical technique.There was a delay of less than 30 minutes, and no further complications were reported.Patient's health condition is stable.
Additional Manufacturer Narrative
H10: internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, during an arthroscopy, when the biosure screw was inserted, it split, leaving 1 cm inside and the rest outside the femoral tunnel.An attempt was made to remove the broken piece, however, it was impossible, it was the decided to leave it inside the patient, since by forcefully removing it, the graft could be damaged.Surgery was completed by changing the surgical technique, the device remained inside the patient doing its proper function, therefore, it was not necessary to drill and additional bone hole, nor a void was left inside the patient.There was a delay of less than 30 minutes, and no further complications were reported.Patient's health condition is stable.The specialist is dissatisfied with the result since the graft remains attached to the bone with only 1cm of the screw.
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 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 review of the material specifications found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.A clinical review states that based on the limited information provided the clinical root cause of the reported biosure screw fracture could not be determined and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.It is unclear if the ifu were adhered to; however, it does caution that ¿excessive force should not be placed on the screw.¿ the material of the biosure screw is made of a biocomposite material which is intended for implantation to allow for bone ingrowth.The patient impact beyond the reported change in surgical technique, possible corrosion, and local irritation/discomfort could not be determined.Please refer to the instructions for use for precautions and warnings related to the use of the device.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.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.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 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 material specifications found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.A clinical review states that based on the limited information provided the clinical root cause of the reported biosure screw fracture could not be determined and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.It is unclear if the ifu were adhered to; however, it does caution that ¿excessive force should not be placed on the screw.¿ the material of the biosure screw is made of a biocomposite material which is intended for implantation to allow for bone ingrowth.The patient impact beyond the reported change in surgical technique, possible corrosion, and local irritation/discomfort could not be determined.All information provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.The patient impact beyond the reported change in surgical technique, possible corrosion, and local irritation/discomfort could not be determined.A visual inspection of the returned device found that it is not in its original packaging.The device was returned with the distal end fractured away.There is biological debris on the returned device.Based on the condition of the product material found during visual inspection, additional material testing is not required.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.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.Corrected data: b1 and h1.
Event or Problem Description
It was reported that, during an arthroscopy, when the biosure screw was inserted, it split, leaving 1 cm inside and the rest outside the femoral tunnel.An attempt was made to remove the broken piece, however, it was impossible, it was the decided to leave it inside the patient, since by forcefully removing it, the graft could be damaged.Surgery was completed by changing the surgical technique, the device remained inside the patient doing its proper function, therefore, it was not necessary to drill and additional bone hole, nor a void was left inside the patient.There was a delay of less than 30 minutes, and no further complications were reported.Patient's health condition is stable.The specialist is dissatisfied with the result since the graft remains attached to the bone with only 1cm of the screw.

• Brand Name: SCREW BIOSURE REGENESORB 8MM X 25MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, 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: 19038886
• Report Number: 1219602-2024-00701
• Device Sequence Number: 7223300
• Product Code: MAI
• UDI-Device Identifier: 00885554036756
• UDI-Public: 00885554036756
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K142948
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2026
• Device Catalogue Number: 72204399
• Device Lot Number: 51133662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 04/03/2024; 05/02/2024; 06/25/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 04/16/2024; 05/06/2024; 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• 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
• Patient Sex: Male