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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS GAUGE, DEPTH
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SYNTHES GMBH DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS GAUGE, DEPTH Back to Search Results
Catalog Number 03.010.072
Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/23/2022
Event Type  malfunction  
Manufacturer Narrative
Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2022, the surgeon was complaining about the ability of the depth gauges to pass easily through the drilled hole and hook onto the far cortex. The tips were seem warped. No patient consequences. This report is for one (1) depth gauge f/lock-scr meas-range-110 f/. This is report 2 of 6 for complaint (b)(4).
 
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Brand NameDEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS
Type of DeviceGAUGE, DEPTH
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES HAEGENDORF GMBH-CN
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13568353
MDR Text Key286361422
Report Number8030965-2022-01021
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.010.072
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2022
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

Patient Treatment Data
Date Received: 02/21/2022 Patient Sequence Number: 1
Treatment
DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/; DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/; DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/; DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/; DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/
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