MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 7MM X 25MM; SCREW, FIXATION, BONE

Catalog Number	72201772
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2023
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, the tip of the biosure broke during employment.All the pieces were removed from the patient with surgical instruments.The procedure was completed with a s+n back up device.There was no surgical delay and no further complications were reported.The back up device was used in the originally bone hole, no voids were left in the patient.
Additional Manufacturer Narrative
H2: additional information ¿b5¿ h3, h6: the reported device was received for evaluation.A visual inspection revealed that they are not in their original packaging.The device has the distal tip fractured, there are cracks running laterally down the device.There is biological debris on the returned items.Based on the condition of the product material found during visual inspection, additional material testing is not required.Insufficient product identification information was provided 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 specifications upon release for distribution.A complaint history review found similar reported events.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 anchor material specification, 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.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that during an arthroscopy, the tip the biosure anchor broke during deployment.All the pieces were removed from the patient with surgical instruments.The procedure was completed with a s+n back up device.There was no surgical delay and no further complications were reported.Bone quality was good, the back up device was used in the originally drilled bone hole, no voids were left in the patient.Instrument used to prepare the insertion site was a s&n: 25mm, tunnel size: 7mm.The site was cleared of all debris.Patient status is good stable.

• Brand Name: BIOSURE HA 7MM 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: 18540477
• Report Number: 1219602-2024-00134
• Device Sequence Number: 21064319
• Product Code: HWC
• UDI-Device Identifier: 03596010611680
• UDI-Public: 03596010611680
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• 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): 02/20/2024

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 Catalogue Number: 72201772
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2023
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown