MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 10MM X 30MM; SCREW, FIXATION, BONE

Model Number	72201786
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the threaded bolt is started, the bolt is released from the bolt body, leaving a burr around the tunnel, the bolt is unusable and requires another bolt.All parts were removed from patient and the same bone hole was used.A backup device was available to complete the procedure with no delay or patient injuries.
Additional Manufacturer Narrative
Examination is not possible, as the device will not be returned.The investigation could not draw any conclusions about the reported event without the return of the device.

• Brand Name: BIOSURE HA 10MM X 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7919396
• Report Number: 1219602-2018-01352
• Device Sequence Number: 13789819
• Product Code: HWC
• UDI-Device Identifier: 03596010611826
• UDI-Public: (01)03596010611826(17)220420(10)50660008
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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: 04/20/2022
• Device Model Number: 72201786
• Device Catalogue Number: 72201786
• Device Lot Number: 50660008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR