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

Model Number	72201887
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zipcode: (b)(6).
Event or Problem Description
It was reported that during surgery, the device on the loan set was damaged and not able to insert a 1.2 guide wire down the cannulated shaft.It seems like the head of the driver was distorted or too tight to fit any wire through.There was no backup device available and it is unknown how the issue was solved.No delay nor patient injury or other complications were reported.
Event or Problem Description
It was reported that during surgery, the device on the loan set was damaged and not able to insert a 1.2 guide wire down the cannulated shaft.It seems like the head of the driver was distorted or too tight to fit any wire through.The procedure was finished with a competitor device.No delay nor patient injury or other complications were reported.
Additional Manufacturer Narrative
One biosure driver was returned for evaluation.Visual assessment of the device showed the distal tip is deformed.The device was tested with a 1.2 guide wire and would not exit the distal tip.The condition of the device indicates it was impacted causing the observed damage.
Additional Manufacturer Narrative
H10/h11: the initial incident report was submitted with incorrect manufacturing site information and registration number 1643264 (s+n oklahoma).The correct manufacturing site information and registration number is 1219602(s+n mansfield).

• Brand Name: BIOSURE DRIVER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048 6512
• MDR Report Key: 8514513
• Report Number: 1643264-2019-00269
• Device Sequence Number: 1465743
• Product Code: HWR
• UDI-Device Identifier: 03596010615398
• UDI-Public: 03596010615398
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/08/2020

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
• Operator of Device: Health Professional
• Device Model Number: 72201887
• Device Catalogue Number: 72201887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 04/16/2019; 04/25/2019; 04/25/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 04/16/2019; 04/26/2019; 02/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1