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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS SAGITTAL SAW ATTACHMENT FOR PEN DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES POWER TOOLS SAGITTAL SAW ATTACHMENT FOR PEN DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 05.001.039
Device Problems Fluid Leak (1250); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Manufacturer Narrative

Lot number unknown; (b)(4). The manufacturing location was unknown. The lot number was unknown; therefore, the device manufacture date was unknown. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

It was reported that during an unspecified surgical procedure, it was discovered that a black fluid/oil was present on the sagittal saw attachment device. According to the reporter, the device was not cleaned properly prior to the procedure and the gap where the saw blade device was connected to was filled with greasy debris. It was reported that the operating room technician present at the time of the incident felt that the residue on her gloves and the patient came from the device. It was reported that the debris present in the surgical site was thoroughly irrigated. There were no delays to the planned surgical procedure as a spare device was available for use to complete the surgery successfully. There were no reports of injuries or prolonged hospitalization. The patient's status post-surgery was unknown. The exact date of the event was unknown. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.

 
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Brand NameSAGITTAL SAW ATTACHMENT FOR PEN DRIVE
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES POWER TOOLS
n/i
n/i
Manufacturer (Section G)
DEPUY SYNTHES POWER TOOLS
n/i
n/i
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6591547
MDR Text Key75977806
Report Number8030965-2017-12533
Device Sequence Number1
Product Code HWE
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK043310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 05/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number05.001.039
Device LOT NumberN/I
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/25/2017 Patient Sequence Number: 1
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