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	06/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when thread the last two turns the dr has a feeling weakness, with the subsequent breakage of the screw core (where the screwdriver is placed) to the outside.A backup device was available to complete the procedure with no delay or patient injuries.
Additional Manufacturer Narrative
One 7x20mm biosure ha screw was returned for evaluation.Visual assessment of the screw confirmed the complaint of breakage.Approximately 7mm of the proximal end of the screw was returned along with three smaller fragments.The outer diameter and wall thickness of the proximal end of the screw was measured and found to meet print specifications.With the limited clinical details provided regarding graft type, size and tunnel size no root cause can be determined.

• 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: 7649415
• Report Number: 1219602-2018-00843
• Device Sequence Number: 1652499
• Product Code: HWC
• UDI-Device Identifier: 03596010611673
• UDI-Public: (01)03596010611673(17)230221(10)50715817
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018

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: 02/21/2023
• Device Model Number: 72201771
• Device Catalogue Number: 72201771
• Device Lot Number: 50715817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1