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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SCREW DEPTH GAUGE EXTREMITY INSTRUMENTS : DEPTH GAUGE

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DEPUY ORTHOPAEDICS INC US SCREW DEPTH GAUGE EXTREMITY INSTRUMENTS : DEPTH GAUGE Back to Search Results
Model Number 2307-91-001
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2022
Event Type  malfunction  
Event Description
It was reported that the plastic depth reader is cracked.
 
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. Investigation summary: examination of the returned device confirmed the reported allegation. Examination of the returned device found the plastic measurement component of the device cracked by the distal end where the measurements engravings end. Additional findings identified during the investigation include the threaded cap on the proximal end was not returned and the proximal end is cross threaded. 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.
 
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Brand NameSCREW DEPTH GAUGE
Type of DeviceEXTREMITY INSTRUMENTS : DEPTH GAUGE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13835431
MDR Text Key287552188
Report Number1818910-2022-05006
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2307-91-001
Device Catalogue Number230791001
Device Lot Number5021485
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2010
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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