MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 7MM X 30MM; SCREW, FIXATION, BONE

Model Number	72201774
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the tibial band was found to be lacerated by the screw.There was no patient injury reported.
Additional Manufacturer Narrative
Device investigation narrative: one 72201774 biosure 7x30mm ha screw returned.Dimensional inspection verifies that this is a 7x30mm product.The anchor is in relatively good condition.During an iliotibial band reconstruction procedure a laceration was found after seating the screw.Report said the screw went in smoothly.The tear was found subsequent to anchoring.The screw does not display any chips, cracks or sharp edges.The iliotibial band was sized as a 5mm and the tunnel was drilled at 6mm.The screw was removed and the band was secured by staple method.There is no symptom supporting the issue being the screw.Ifu says: ¿prep per the ifu recommendation is critical for ease of insertion and successful anchoring¿ and also ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device¿.There is much preparation to the tendon where other instruments may have come in contact with the tissue.During the procedure there was a guide wire and possibly instruments used that could be more abrasive than the screw used.No root cause related to the manufacturing of this device can be confirmed.(b)(4).

• Brand Name: BIOSURE HA 7MM X 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6866613
• Report Number: 1219602-2017-01145
• Device Sequence Number: 16453644
• Product Code: HWC
• UDI-Device Identifier: 03596010611703
• UDI-Public: (01)03596010611703(17)210217(10)50587275
• Combination Product (Y/N): N
• PMA/510(K) Number: K080358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/17/2021
• Device Model Number: 72201774
• Device Catalogue Number: 72201774
• Device Lot Number: 50587275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR