MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 9MM X 30MM; SCREW, FIXATION, BONE

Model Number 72201782

Device Problem Failure to Align (2522)

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

Event Date 01/26/2022

Event Type  Injury  

Event Description

It was reported that, during an acl reconstruction, while making the tibial tunnel using the 9x3 biosure ha, it was noticed that it was loose.This surgery was a revision and there was already another tunnel, as it was a patellar graft and the screw did not take hold, a 11x30 screw was used.Surgery was resumed, after a non-significant delay.No patient complications were reported.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during an acl reconstruction, while making the tibial tunnel using the 9x3 biosure ha, it was noticed that it was loose.This surgery was a revision and there was already another tunnel, as it was a patellar graft and the screw did not take hold, a 11x30 screw was used.Surgery was resumed, after a non-significant delay.No patient complications were reported.

Manufacturer Narrative

H10: 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.There was no way to determine if the device contributed to the reported event.The provided product identification information did not match any known release of this part and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.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 that the anticipated risk region is not adequate.A clinical review states that no relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.There was no relationship found between the device and the reported event.The complaint was not confirmed.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.

Event Description

It was reported that, during an acl reconstruction, while making the tibial tunnel using the biosure ha, it was noticed that it was loose.This surgery was a revision and there was already another tunnel, as it was a patellar graft and the screw did not take hold, a larger screw was used.Surgery was resumed, after a non-significant delay.No patient complications were reported.

• Brand Name: BIOSURE HA 9MM X 30MM
• Type of Device: 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: 13553119
• MDR Text Key: 285813623
• Report Number: 1219602-2022-00249
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010611789
• UDI-Public: 03596010611789
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K080358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201782
• Device Catalogue Number: 72201782
• Device Lot Number: 2058712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 12/28/2022
• Supplement Dates FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 39 YR
• Patient Sex: Male