MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWER SAGITTAL SAW; SAW, POWERED, AND ACCESSORIES

Model Number	7205786
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Preliminary assessment by investigator on 6-dec-2017 determined that device overheats in the laboratory.Evaluation of the device in on going by the investigator, final results will be included in the supplemental mdr.
Event or Problem Description
It was reported that during the routine inspection the device did not move.No patient was involved.
Additional Manufacturer Narrative
The device was received and sent to the original equipment manufacturer (oem) for evaluation.There was a relationship found between the returned device and the reported incident.Evaluation of the device by the oem found the unit overheated.Upon disassembly it was noted that the motor was seized.The complaint was confirmed and the root cause has been associated with a mechanical component failure.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

• Brand Name: DYONICS POWER SAGITTAL SAW
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7088995
• Report Number: 1643264-2017-01808
• Device Sequence Number: 903577
• Product Code: HAB
• UDI-Device Identifier: 03596010410719
• UDI-Public: (01)03596010410719
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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: 7205786
• Device Catalogue Number: 7205786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1