• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS DRILL BIT Ø4 W/CENTER-TIP L148/122 3FLUT INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY SYNTHES POWER TOOLS DRILL BIT Ø4 W/CENTER-TIP L148/122 3FLUT INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 511.417
Device Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/26/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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
This is report 2 of 2 for the same event. It was reported from (b)(6) that during a surgical procedure for humeral diaphysis fracture to apply (b)(6) proximal femoral nail antirotation (pfna) blade-long device, it was observed that the radiolucent drive device stopped spinning the drill bit device while the surgeon was performing the distal locking. It was reported that the event occurred when the tip of the drill bit device came into contact with the opposite side of the proximal cortical bone after drilling and penetrating the proximal cortical bone of the patient's femur. It was reported that the distal locking procedure was completed by attaching the drill bit device directly to the power tool device. It was reported that there was a five minute delay in the surgical procedure. It was not reported if a spare device was available for use. It was reported that there was no alleged malfunction against the pfna (proximal femoral nail antirotation) device. There was patient involvement reported. It was not reported if there were any injuries, medical intervention or prolonged. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
(b)(4). The previous report stated the lot number as unknown. It has been updated to reflect the actual lot number (u135909). The manufacturer location was documented as unknown in the initial report. The location has been updated to (b)(4). Contact office name/address have been updated accordingly to reflect the corrected manufacturing facility. The previous report stated the date of manufacture (dom) was unknown. It has been updated to reflect the date (nov 15, 2011) the device was manufactured. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
The actual device was returned for evaluation. Reliability engineering evaluated the device and the reported condition was confirmed. The assignable root cause was determined to be due to wear from normal use over time. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDRILL BIT Ø4 W/CENTER-TIP L148/122 3FLUT
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES POWER TOOLS
hauptstrasse 24
waldenburg CH443 7
SZ CH4437
Manufacturer (Section G)
DEPUY SYNTHES POWER TOOLS
hauptstrasse 24
waldenburg CH443 7
SZ CH4437
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5940195
MDR Text Key54782569
Report Number8030965-2016-14767
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number511.417
Device Lot NumberU135909
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/09/2016 Patient Sequence Number: 1
Treatment
POWER TOOL DEVICE; PROXIMAL FEMORAL NAIL ANTIROTATION; RADIOLUCENT DRIVE DEVICE
-
-