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

Catalog Number 72201774

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the ratchet screwdriver pushed through the distal tip of the biosure ha 7mm x 30mm causing the screw to be stuck on the screwdriver.The entire screw and screwdriver were removed from the patient.The procedure was completed with a back up device.A slight delay to surgery occurred (0-30min) to allow for time to remove the screw and replace it.No patient injury occurred as a result.

Manufacturer Narrative

Device investigation narrative - a review of the ncmr database was performed which confirmed no abnormalities were reported with this lot during manufacture.A complaint history review identified no additional complaints for this manufactured lot.Examination was not possible, as the devices will not be returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event without the return of the devices.Further investigation is not warranted at this time.Evaluation codes updated to indicate that manufacturing review was performed.(b)(4).

• Brand Name: BIOSURE HA 7MM 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5833965
• MDR Text Key: 51735279
• Report Number: 1219602-2016-00446
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K080358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 72201774
• Device Lot Number: 50485199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2013
• 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