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	12/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery biosure ha screw broke.No patient injury reported.Back up device was available.Broken pieces were removed from the patient's anatomy.
Additional Manufacturer Narrative
One 8x30mm biosure ha screw was returned for evaluation.Visual assessment of the screw confirmed the complaint.The first distal thread has broken off and was not returned for evaluation.The screws major diameter and wall thickness was measured and found to meet print specifications.With the limited clinical details provided regarding patient bone quality, graft type and size as well as tunnel preparation a root cause cannot be determined.This investigation could not identify any evidence of product contribution to the reported complaint.Further investigation is not warranted at this time.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product or the pertinent clinical details to consider.As such the complaint is being closed without conclusion.

• 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: 8196605
• Report Number: 1219602-2018-01786
• Device Sequence Number: 1672904
• Product Code: HWC
• UDI-Device Identifier: 03596010611741
• UDI-Public: 03596010611741
• Combination Product (Y/N): N
• PMA/510(K) Number: K080358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2019

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: 02/21/2022
• Device Catalogue Number: 72201778
• Device Lot Number: 50648505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Initial Date Received by Manufacturer: 12/16/2018
• Supplement Date Received by Manufacturer: 01/30/2019; 02/27/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/31/2019; 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 68