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

Model Number	72201778
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
International zip code: (b)(6).
Event or Problem Description
It was reported that during surgery, the screw cracked on the side after inserting the graft.No significant delay or patient injuries were reported.It is unknown how the procedure was completed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: the reported 8x30mm biosure ha screw intended for use in treatment, was not returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the screw broke during insertion.Without the screw and pertinent clinical details regarding graft type, tunnel size and patient bone quality an exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not using a tap in hard bone applications.Not preparing the tibial and femoral tunnels in accordance with the accepted surgical technique.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 9809276
• Report Number: 1219602-2020-00490
• Device Sequence Number: 778322
• 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: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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: 07/10/2023
• Device Model Number: 72201778
• Device Catalogue Number: 72201778
• Device Lot Number: 50746140
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 04/08/2020
• 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