MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOTOR DRIVE UNIT,NON-HAND CNTL,PWRMX; SAW, POWERED, AND ACCESSORIES

Model Number 72200617

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Burn, Thermal (2530)

Event Date 04/14/2015

Event Type  Injury  

Event Description

Customer reported while surgeon was making the incision and vertebral puncture, the patient¿s leg shook after inserting smith & nephew blade.Surgeon thought it was due to insufficient anesthesia, so the anesthesia was strengthened to proceed with procedure.A skin burn was found on patient offside the blade, after procedure.The blade was taken out to find burnt like area on its front.The engineer performed a test to simulate actual operation condition and no electric leakage was found.Patient¿s burn was cleaned and bandaged, however the next day found the wound to be more serious than expected.Patient underwent skin graft surgery on (b)(6).((b)(4)).

Manufacturer Narrative

The device was marked as available for evaluation; although anticipated, the device has not yet been received.(b)(4).

Manufacturer Narrative

One non-hand control powermax elite motor drive unit, part number 72200617 was received on 11 june 2015 and confirmed to be serial number (b)(4).A visual inspection was performed on the product and no damage was found.Complaint of skin burn could not be confirmed.Product passed functional testing per process summary and high speed testing (100-10,000 rpms) with 3 different type blades installed.Unit passed functional tests on both dyonics power, dii and dii eip test control units with and without footswitch.Current draw was below average for this product and no damage occurred to test blades during functional testing.After evaluating the product no problem was found.The product was shipped to the customer new on (b)(6) 2014.(b)(4).

• Brand Name: MOTOR DRIVE UNIT,NON-HAND CNTL,PWRMX
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4781505
• MDR Text Key: 18092553
• Report Number: 1643264-2015-00013
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200617
• Device Catalogue Number: 72200617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2014
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 68