MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS SAGITTAL MICRO SAW; DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)

Catalog Number S-SAW_LL

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

Device returned for repaired.During the inspection the technician found the device was frozen and oil leaking from swivel and shift lever.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities related to synthes ous service and repair files legacy review/remediation protocol-complaint handling and mdr reporting.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.During pre-repair assessment performed by technician, during the inspection the technician found the device was frozen and oil leaking from swivel and shift lever.The device was repaired and returned to customer.

• Brand Name: SAGITTAL MICRO SAW
• Type of Device: DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 4175804
• MDR Text Key: 5101126
• Report Number: 1045834-2014-14112
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PK831756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2013

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: S-SAW_LL
• Device Lot Number: 050000263990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2013
• Initial Date FDA Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1