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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 SCREW DEPTH GAUGE EXTREMITY INSTRUMENTS : DEPTH GAUGE

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DEPUY FRANCE SAS - 3003895575 SCREW DEPTH GAUGE EXTREMITY INSTRUMENTS : DEPTH GAUGE Back to Search Results
Catalog Number 230791001
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/24/2018
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
Depth guage missing black plastic piece that screws onto end. Was able to use. Locking screwdriver - x1 of the 4 rectangular tines at tip of screwdriver noted to be missing.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: the device associated with the reported event was not received for evaluation. 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 NameSCREW DEPTH GAUGE
Type of DeviceEXTREMITY INSTRUMENTS : DEPTH GAUGE
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR 69801
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. US 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380
6103142063
MDR Report Key7995789
MDR Text Key124712478
Report Number1818910-2018-73260
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number230791001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2018
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 Unkown

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