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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 3.8MM DRILL BIT 25MM; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
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DEPUY ORTHOPAEDICS INC US 3.8MM DRILL BIT 25MM; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS Back to Search Results
Model Number 2366-84-000
Device Problems Break (1069); Entrapment of Device (1212); Material Twisted/Bent (2981)
Patient Problem Not Applicable (3189)
Event Date 01/31/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).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 the drill bit was broken when drilling for fixation of the cup screw during the tha surgery on (b)(6) 2020.The bone was strong and difficult to drill, and as a result of the surgeon twisted the drill bit slightly, the tip of the drill bit was broke and about 1/3 of the drill bit was remained in the acetabular.It was judged that it was difficult to remove it and the fragment part was remained in the patient¿s body.The surgery was completed within a 30 minutes surgical delay.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : the device was reviewed by bioengineering and a report was received stating; it was unlikely that a manufacturing defect was present.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
3.8MM DRILL BIT 25MM
Type of Device
DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key9727403
MDR Text Key190660546
Report Number1818910-2020-05262
Device Sequence Number1
Product Code HTW
UDI-Device Identifier10603295120186
UDI-Public10603295120186
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup,Followup,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2366-84-000
Device Catalogue Number236684000
Device Lot NumberNG80818
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2020
Date Manufacturer Received04/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age80 YR
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