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	06/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during an acl reconstruction surgery, the biosure screw tip broke while being inserted into the tibial tunnel.All fragments were retrieved from the patient's anatomy by using an artery.A back-up device was used, in the same bone hole, to complete the procedure.The surgery was not significantly delayed.The patient was not injured.
Additional Manufacturer Narrative
One 72201785 10x25mm biosure ha screw used for treatment, was returned for evaluation.The complaint stated: ¿the biosure screw tip broke while being inserted into the tibial tunnel.¿ dimensional inspection verifies that this was a 10x25mm product.The screw was used for an acl reconstruction.Clinical information conveyed that the procedure was conducted according to all recommendations.The head of the product is in good condition.The distal threads were rolled and compressed.This is aligned with force during seating attempt.¿per instructions for use: ¿in cases where hard bone is encountered, it is recommended that a tap 1 mm larger than the screw size be used.Prep per the instructions for use recommendation is critical for ease of insertion and successful anchoring.The starter must be utilized with the biorci screws to minimize screw breakage during insertion.Excessive force should not be placed on the delivery instrument.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.¿ the condition of the implant indicates a torque issue.No root cause related to the manufacturing of this device was confirmed.Product met specifications upon release to distribution.
Additional Manufacturer Narrative
One sterile 72201785 10x25mm biosure ha screw used for treatment but was not returned for evaluation.Due to product unavailability, physical evaluation, full investigation and conclusions were limited.Product met specifications upon release to distribution.Complaint history review found no other reports for this lot.

• 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: 8787025
• Report Number: 1219602-2019-00807
• Device Sequence Number: 11262341
• Product Code: HWC
• UDI-Device Identifier: 03596010611819
• UDI-Public: 03596010611819
• 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): 09/26/2019

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: 10/31/2023
• Device Catalogue Number: 72201785
• Device Lot Number: 50767645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 08/12/2019; 09/25/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/14/2019; 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1