MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 11MM X 30MM; SCREW, FIXATION, BONE

Model Number	72201789
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a lca surgery the device broke when the doctor was doing the graft attachment.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 11x30mm biosure ha screw intended for use in treatment, was not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.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 was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.This investigation could not identify any evidence of product contribution to the reported complaint.
Additional Manufacturer Narrative
H10 h3, h6: the reported 11x30mm biosure ha screw, used in treatment, has been returned for evaluation.Visual assessment of the screw confirmed the reported breakage.Approximately 6mm of the distal threads have broken off and were not returned for examination.Dimensional assessment of the screws major diameter and wall thickness was performed and found to meet print specifications.Without the pertinent clinical details regarding graft type and tunnel size 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 techniques.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 complaint records was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

• Brand Name: BIOSURE HA 11MM X 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9302686
• Report Number: 1219602-2019-01395
• Device Sequence Number: 2104313
• Product Code: HWC
• UDI-Device Identifier: 03596010611857
• UDI-Public: 03596010611857
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2020

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: 05/23/2024
• Device Model Number: 72201789
• Device Catalogue Number: 72201789
• Device Lot Number: 50807335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 12/06/2019; 01/27/2020
• Initial Report FDA Received Date: 11/10/2019
• Supplement Report FDA Received Date: 12/11/2019; 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR