MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 10MM X 30MM; SCREW, FIXATION, BONE

Catalog Number	72201786
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during the passage of the screw, the screw lost its adherence that enveloped it and it did not attach to graft.There was no delay or patient injuries reported.There was no back-up available to finish the procedure.
Additional Manufacturer Narrative
One 10x30mm biosure ha screw was returned for evaluation.Visual assessment of the screw confirmed the complaint.A majority of the screws threads have been damaged/deformed and are missing pieces.The screws major diameter, length and wall thickness were measured and found to meet print specifications.An exact root cause cannot be determined with confidence with the limited clinical details provided; however, factors that could have contributed to the reported event include: improper site preparation for bone quality or tunnel size.Excessive force placed on the screw during insertion.The instruction for use were reviewed and were 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.
Additional Manufacturer Narrative
The reported 10mm x 30mm biosure ha intended for use in treatment, will not be 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 would not purchase during insertion.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: improper preparation of the insertion site.Use in pathological conditions of bone, such as tumors, severe osteoporosis, and skeletal immaturity, may impair the ability to securely fix or anchor the device.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that during the passage of the screw, the screw lost its adherence that enveloped it and it did not attach to graft, the screw broke inside the patient the procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
Event description updated since new information was received.

• Brand Name: BIOSURE HA 10MM X 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8633212
• Report Number: 1219602-2019-00590
• Device Sequence Number: 1876250
• Product Code: HWC
• UDI-Device Identifier: 03596010611826
• UDI-Public: 03596010611826
• 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,Followup
• Report Date (Section B): 10/21/2019

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 Catalogue Number: 72201786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 06/12/2019; 06/14/2019; 10/18/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/12/2019; 06/17/2019; 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1