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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES COMPANIES / DEPUY INTL., LTD. SYNTHES DEPTH GAUGE GAUGE, DEPTH

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DEPUY SYNTHES COMPANIES / DEPUY INTL., LTD. SYNTHES DEPTH GAUGE GAUGE, DEPTH Back to Search Results
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/03/2022
Event Type  Injury  
Event Description
Physician used the synthes depth gauge properly. He hooked the far cortex of the bone to assess the screw length, and in the process, the tip of the depth gauge broke off. The fragment generated remained in the patient, as shown by intra-operative imaging. Physician then retrieved the fragment. No fragments remained in patient as shown by intra-operative imaging. The case was completed successfully with an estimated time delay of 60 minutes per physician. Fda safety report id# (b)(4).
 
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Brand NameSYNTHES DEPTH GAUGE
Type of DeviceGAUGE, DEPTH
Manufacturer (Section D)
DEPUY SYNTHES COMPANIES / DEPUY INTL., LTD.
west chester PA
MDR Report Key14345624
MDR Text Key291376491
Report NumberMW5109602
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 Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 05/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/09/2022 Patient Sequence Number: 1
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