MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EXTREM INSTRUMENTS; GRASPER

Model Number 013219

Device Problems Computer Software Problem (1112); Nonstandard Device (1420)

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

Event Date 01/26/2015

Event Type  Injury  

Event Description

During an ankle arthroscopy procedure on (b)(6) 2015 the surgeon was trying to remove a loose body and the jaw broke in two pieces.The surgery was successfully completed with a back-up device.However information provided indicates that the broken piece of the device was left in the patient.On (b)(6) 2015 a second surgical procedure was performed to remove the broken piece using a grasper without any issues.The surgeon is confident that no debris remained in the patient and post-op condition was noted to be ok.

Manufacturer Narrative

Device evaluation anticipated but not yet begun.A follow-up report will be filed upon completion of the device analysis.(b)(4).

• Brand Name: EXTREM INSTRUMENTS
• Type of Device: GRASPER
• 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: donna lanteigne ; 150 minuteman road; andover, MA 01810 ; 9787491576
• MDR Report Key: 4642130
• MDR Text Key: 5576191
• Report Number: 1219602-2015-00052
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/02/2015

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 Model Number: 013219
• Device Catalogue Number: 013219
• Device Lot Number: 1203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 03/30/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR