MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 11MM X 30MM; SCREW, FIXATION, BONE

Model Number	72201789
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the driver is not seating inside the screw fully.Still when they tried rotating and to put the screw in the bone, the screw driver started moving inside the screw.No patient injuries were reported.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.No further actions pursued at this time.If objective evidence, relevant information or product becomes available to assist with evaluation, the complaint will certainly be revisited.A dhr review was performed by querying historical data of the ncmr and complaint databases.Complaint history search revealed no other complaints for this production lot.
Additional Manufacturer Narrative
One 72201789 11x30mm biosure ha screw returned.Dimensional inspection verifies that this is an 11x30mm product.There were chartstik labels for this product as well as a 10x25mm screw.The complaint stated: "as reported: when biosure screw driver was inserted in biosure ha screw, they complained that the driver is not seating inside the screw fully.Still when they tried rotating and to put the screw in the bone, the screw driver started moving inside the screw.When the screw was removed to check they found that the screw internal plus shaped grids were broken or sort of worn out during rotation.Unfortunately the screw couldn't be used.We then used the biorci ha screw which was available in the same size as backup." there is damage to the outer diameter.There are marks from the guidewire.The plus head was found extremely stripped from over torque.The second, successfully implanted product was a smaller diameter and shorter product per the labels provided.The description of the event and the condition of the screw indicates that the 11x30mm product met with excess resistance from a tunnel that was too tight.Maximum surface to surface intent is achieved with interference style screws by use of same size tunnel allowing the screw threads to make optimum surface to surface contact.A smaller tunnel increases the risk of torque damage.No root cause related to the manufacturing of this device was confirmed.

• Brand Name: BIOSURE HA 11MM X 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7674501
• Report Number: 1219602-2018-00869
• Device Sequence Number: 1554762
• Product Code: HWC
• UDI-Device Identifier: 03596010611857
• UDI-Public: (01)03596010611857(17)230103(10)50705705
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2018

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: 01/03/2023
• Device Model Number: 72201789
• Device Catalogue Number: 72201789
• Device Lot Number: 50705705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 08/09/2018; 09/11/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/13/2018; 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1