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

Catalog Number	72201774
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the point of the product, broke.All pieces were removed from patient.A backup device was available to complete the procedure with no delay or patient injuries.
Additional Manufacturer Narrative
One 72201774 biosure 7x30mm ha screw used for treatment, was partially returned for evaluation.The complaint stated: ¿the point of the product, broke.¿ dimensional inspection verified this was a 7 x 30mm product.Approximately 4mm of the distal tip was fractured off.The item displayed a torn distal tip with jagged sharp edges.The symptoms are consistent with force.This may occur from entanglement with another instrument or device.It is also consistent with excess torque applied as when unexpected bone density is encountered or an inadequate diameter tunnel.Per instructions for use: ¿prep per the instructions for use recommendation is critical for ease of insertion and successful anchoring.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device¿.No root cause related to the manufacturing of this device was confirmed.Product met specifications upon release to distribution.

• 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: 9150817
• Report Number: 1219602-2019-01194
• Device Sequence Number: 11559763
• Product Code: HWC
• UDI-Device Identifier: 03596010611703
• UDI-Public: 03596010611703
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 11/10/2019

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: 07/10/2023
• Device Catalogue Number: 72201774
• Device Lot Number: 50746137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 10/03/2019; 11/07/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 10/03/2019; 11/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR