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	03/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw was damaged during surgery.The procedure was successfully completed without significant delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The reported 10mm x 30mm biosure ha screw intended for use in treatment, has not been returned for evaluation.Without the reported product and pertinent clinical details a thorough investigation cannot be performed and the customers complaint confirmed.From the information provided: the screw got damaged 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.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
One 10x30 biosure-ha screw was returned for evaluation.Visual assessment of the screw confirmed the reported complaint.The screws distal threads are broken and deformed.Clinical details regarding site preparation, graft type and patient bone quality were not supplied.The condition of the device indicates the anchor was subjected to excessive force and off axis insertion.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: improper site preparation, incorrect screw size.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.

• 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: 8587792
• Report Number: 1219602-2019-00511
• Device Sequence Number: 11307825
• Product Code: HWC
• UDI-Device Identifier: 03596010611826
• UDI-Public: 03596010611826
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2019

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: 10/07/2023
• Device Catalogue Number: 72201786
• Device Lot Number: 50746147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 06/24/2019; 07/09/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/24/2019; 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1