MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK, 10 X 25MM

Model Number 72202276

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 01/01/1901

Event Type  Injury  

Event Description

On (b)(6), during an achilles allograft procedure a biosure pk screw was implanted.The site for the screw had been prepped with a drill or reamer.Approximately six months post-procedure (exact date unknown), the patient went to the physician for a scheduled visit.The patient informed the physician that the screw was becoming notably prominent.The surgeon determined that the screw was backing out.During a second procedure, the surgeon made a small incision, twisted the screw twice and removed it from the patient.The screw was intact and the area looked healed.There was no report of pain or further complications.The patient¿s bone quality was good.

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.A review of the device history records and quality records associated with this manufactured lot confirmed that no abnormalities were reported with this product lot during manufacture.(b)(4).

• Brand Name: BIOSURE PK, 10 X 25MM
• Type of Device: BIOSURE PK
• 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: brenda driscoll ; 150 minuteman road; andover, MA 01810 ; 9787491462
• MDR Report Key: 4576236
• MDR Text Key: 5453343
• Report Number: 1219602-2015-00037
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: 72202276
• Device Catalogue Number: 72202276
• Device Lot Number: 50334931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 03/06/2015
• Date Device Manufactured: 06/01/2010
• 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 Outcome(s): Required Intervention