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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 S/C TRIAL HANDLE ANGLED; HIP INSTRUMENTS : HANDLES

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DEPUY ORTHOPAEDIC INC, 1818910 S/C TRIAL HANDLE ANGLED; HIP INSTRUMENTS : HANDLES Back to Search Results
Catalog Number 205513000
Device Problem Difficult to Insert (1316)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/14/2018
Event Type  malfunction  
Manufacturer Narrative
(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
Der states that one of the spring loaded ¿ball bearings¿ on the handle for endo head trials was seized up and won¿t move therefore making it extremely difficult to connect head trials.A different handle was used to complete the case with no delay.
 
Manufacturer Narrative
Product complaint # : (b)(4).Examination of the returned instrument confirmed the complaint.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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
S/C TRIAL HANDLE ANGLED
Type of Device
HIP INSTRUMENTS : HANDLES
Manufacturer (Section D)
DEPUY ORTHOPAEDIC INC, 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDIC INC, 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582
5743725905
MDR Report Key7233648
MDR Text Key98754813
Report Number1818910-2018-52505
Device Sequence Number1
Product Code HWA
UDI-Device Identifier10603295084488
UDI-Public10603295084488
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 01/14/2018
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
Device Operator Health Professional
Device Catalogue Number205513000
Device Lot NumberPG0702
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/14/2018
Initial Date FDA Received02/01/2018
Supplement Dates Manufacturer Received01/24/2018
07/02/2018
Supplement Dates FDA Received02/13/2018
07/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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