MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE INSTRUMENTS; BIOSURE RATCHET DRIVER

Model Number 72201888

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2015

Event Type  malfunction  

Event Description

Incorrect marking - this unit arrived at the distribution center as marked - not for human use.The unit was sent out to a customer by a materials staff member as they were not aware of this when it shipped.No case, no patient impact.

Manufacturer Narrative

Although anticipated, the device has not been received for analysis.(b)(4).

Manufacturer Narrative

Two devices were returned for evaluation.It was confirmed that the parts are laser marked with ¿not for human use.¿ as a result of this incident a corrective and preventative action has been initiated.The root cause investigation is underway.(b)(4).

• Brand Name: BIOSURE INSTRUMENTS
• Type of Device: BIOSURE RATCHET DRIVER
• 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: meaghan atwell ; 150 minuteman road; andover, MA 01810 ; 9787491317
• MDR Report Key: 4791730
• MDR Text Key: 5815874
• Report Number: 1219602-2015-00110
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,company representati
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/23/2015

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
• Device Operator: Other
• Device Model Number: 72201888
• Device Catalogue Number: 72201888
• Device Lot Number: 50536704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1