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

Model Number 72201786

Device Problem Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2018

Event Type  malfunction  

Event 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.

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
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 w. william canon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 7919396
• MDR Text Key: 122452789
• Report Number: 1219602-2018-01352
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010611826
• UDI-Public: (01)03596010611826(17)220420(10)50660008
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K080358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR