MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 7MM X 20MM; SCREW, FIXATION, BONE

Model Number	72201771
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the biosure broke when trying to insert it.No patient injury was reported.
Additional Manufacturer Narrative
One 72201771 7x20mm biosure ha screw returned.The product is less than one year old.Dimensional inspection confirms that this is a 7mm product.There is a 2.7mm piece missing from the distal tip of the anchor.This was not returned.The complaint said: ¿the biosure broke when trying to insert it¿.The screw has been fractured.It also has compressed threads.This would indicate force and over-torque.Prep per the ifu recommendation is critical for ease of insertion and successful anchoring.The ifu says: ¿excessive force should not be placed on the delivery instrument¿ and ¿the starter must be utilized with the biorci screws to minimize screw breakage during insertion.¿ it is unknown whether recommendations were followed.Details such as type and size of tap, size of tunnel drilled, procedure conducted and patient bone condition were not included.The physical condition indicates difficulty with proper insertion.No root cause related to the manufacturing of this device can be confirmed.

• Brand Name: BIOSURE HA 7MM X 20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7048704
• Report Number: 1219602-2017-01446
• Device Sequence Number: 903274
• Product Code: HWC
• UDI-Device Identifier: 03596010611673
• UDI-Public: (01)03596010611673(17)220518(10)50665120
• 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: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

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: 05/18/2022
• Device Model Number: 72201771
• Device Catalogue Number: 72201771
• Device Lot Number: 50665120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1