MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 10MM X 25MM; SCREW, FIXATION, BONE

Model Number	72201785
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported 10x25mm biosure has screw, used in treatment, has been returned for evaluation.Visual assessment of the screw showed a majority of the treads are deformed and are missing pieces.Dimensional assessment of the screws major diameter and wall thickness was performed and found to meet print specifications.Without the pertinent clinical details regarding patient bone quality, graft type and size as well as tunnel size an exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during use.Improper site preparation.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.Further investigation is not warranted at this time.
Event or Problem Description
It was reported that during an acl reconstruction surgery, the screw was found thread crooked.However, there was no breakage into the patient.Backup device was available to complete the procedure.No significant delay and no patient injuries were reported.Results of investigation have concluded that the device was deformed and it was missing pieces and was actually used 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 10MM X 25MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9803953
• Report Number: 1219602-2020-00481
• Device Sequence Number: 643094
• Product Code: HWC
• UDI-Device Identifier: 03596010611819
• UDI-Public: 03596010611819
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/08/2020

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: 01/13/2020
• Device Model Number: 72201785
• Device Catalogue Number: 72201785
• Device Lot Number: 50534163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 03/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR