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

Catalog Number	72201789
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported 11x30mm biosure ha screw intended for use in treatment, has been returned for evaluation.Visual assessment of the device confirmed the reported complaint.Approximately.390 of the distal threads have been deformed and are missing pieces.Dimensional assessment of the screws major diameter and wall thickness were found to meet print specification.Without the 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.(b)(6).
Event or Problem Description
It was reported that, during the surgery, when the surgeon started to screw there was an issue with the screw thread.A backup device was available to complete the procedure with no delay or patient injuries.Results of investigation have concluded that this screw broke inside the patient which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• 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: 9248327
• Report Number: 1219602-2019-01331
• Device Sequence Number: 11276429
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2019

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: 12/06/2023
• Device Catalogue Number: 72201789
• Device Lot Number: 50774360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1