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

Catalog Number	72201785
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a reconstruction of the anterior cruciate ligament (right knee), the thread of the screw broke during the implantation, the pieces were removed using tweezers.There was a surgical delay greater than 30 minutes.A backup device was available to complete the procedure with no patient injuries.
Additional Manufacturer Narrative
One 10x25 biosure-ha screw was returned for evaluation.Visual assessment of the screw confirmed the reported complaint of breakage.Approximately.5mm of the distal threads have broken off and were not returned for examination.Clinical details regarding site preparation, graft type and patient bone quality were not supplied.The condition of the device indicates the screw was subjected to excessive force.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 25MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8756125
• Report Number: 1219602-2019-00772
• Device Sequence Number: 2280762
• Product Code: HWC
• UDI-Device Identifier: 03596010611819
• UDI-Public: 03596010611819
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

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: 72201785
• Device Lot Number: 50774354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 07/09/2019
• 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
• Patient Weight: 82