MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 8 MM X 30MM; SCREW, FIXATION, BONE

Catalog Number	72201778
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a treatment at the insertion of the screw in the femur, the screw broke inside the patient, all the pieces were removed with tweezers.A backup device was used to complete the surgery.No significant delay or patient injury reported.
Additional Manufacturer Narrative
The reported 8 mm x 30mm biosure ha screw, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product has not been returned and the pertinent clinical details have not been provided.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the screw broke, causing debris in the patient.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: inappropriate size screw.Not using a tap in hard bone applications.Not preparing the tibial and femoral tunnels in accordance with the accepted surgical technique.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that during a treatment at the insertion of the screw in the femur, the screw broke inside the patient, all the pieces were removed with tweezers.A backup device was used to complete the surgery.No delay or patient injury reported.

• Brand Name: BIOSURE HA 8 MM X 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8436661
• Report Number: 1219602-2019-00316
• Device Sequence Number: 3056850
• Product Code: HWC
• UDI-Device Identifier: 03596010611741
• UDI-Public: 03596010611741
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K080358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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: 10/07/2023
• Device Catalogue Number: 72201778
• Device Lot Number: 50746140
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR