MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP ACCESS CONSUMABL; GUIDEWIRE,NITINOL,1.2 X 45L(3)

Catalog Number 7205395

Device Problems Bent (1059); Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was not possible due to a lot number not being provided.No further investigation is warranted at this time.

Event Description

Nitinol guidewire broke in the patient.The guidewire was repeatedly inserted into the joint and at some point it bent and a portion snapped off.The surgeon managed to recover the broken off portion using graspers and continued with the procedure using a backup device.The case was completed with no patient injury or further problems.

• Brand Name: HIP ACCESS CONSUMABL
• Type of Device: GUIDEWIRE,NITINOL,1.2 X 45L(3)
• 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: jim gonzales ; 150 minuteman road; andover, MA 01810
• MDR Report Key: 5792517
• MDR Text Key: 50137854
• Report Number: 1219602-2016-00380
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2013

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: Health Professional
• Device Catalogue Number: 7205395
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2013
• Initial Date FDA Received: 07/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR