MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 8MM X 25MM; SCREW, FIXATION, BONE

Model Number 72201776

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that after opening the biosure-ha 8 mm x 25 mm package, it was found that the screw was a hexagon socket screw when normally, the screw was a quadrangle socket screw.It is unknown when the event happened, if there was patient involvement, if there was a delay and if a backup device was available.

Manufacturer Narrative

Internal complaint reference case (b)(4).H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Additional information received states that this event occurred in a warehouse before the device was released.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: BIOSURE HA 8MM X 25MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11467757
• MDR Text Key: 239353728
• Report Number: 1219602-2021-00506
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010611727
• UDI-Public: 03596010611727
• Combination Product (y/n): N
• PMA/PMN Number: K080358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201776
• Device Catalogue Number: 72201776
• Device Lot Number: 50819411
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1