MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 10MM X 25MM; SCREW, FIXATION, BONE

Model Number	72201785
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the head of anchor was broken during the implantation in a cruciate ligament reconstruction.No patient injuries were reported.
Additional Manufacturer Narrative
Dimensional inspection verifies that this is a 10x25mm product.It is two years old.The product was used for a cruciate ligament reconstruction procedure.The complaint listed: ¿the head of the anchor was broken¿.It also states that the pieces were removed from the patient.The head and threads were found to be damaged.The head is stripped.The threads were found to be rolled and compressed.The symptoms indicate that force was placed upon the implant.The condition of the implant indicates a torque issue.No root cause related to the manufacturing of this device can be confirmed.There are indications that the event may be attributed to use error.

• Brand Name: BIOSURE HA 10MM X 25MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6764761
• Report Number: 1219602-2017-00850
• Device Sequence Number: 16496886
• Product Code: HWC
• UDI-Device Identifier: 03596010611819
• UDI-Public: (01)03596010611819(17)201016(10)50570169
• 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: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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 Model Number: 72201785
• Device Catalogue Number: 72201785
• Device Lot Number: 50570169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR