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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DEPTH GAUGE FOR 2.0MM/2.4MM AND 2.7MM SCREWS GAUGE, DEPTH

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OBERDORF SYNTHES PRODUKTIONS GMBH DEPTH GAUGE FOR 2.0MM/2.4MM AND 2.7MM SCREWS GAUGE, DEPTH Back to Search Results
Catalog Number 03.111.005
Device Problems Material Twisted/Bent (2981); Mechanical Jam (2983); Naturally Worn (2988)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/16/2018
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. 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) 2018, before the surgery, the nurse found that the depth gauge that was delivered did not move smoothly at all. It was confirmed that the depth gauge could not be used in the surgery. Another set was delivered to be used to complete the procedure. There was no adverse consequence to the patient. Procedure was completed successfully. This report is for one (1) depth gauge for 2. 0mm/2. 4mm and 2. 7mm screws. This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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.
 
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Brand NameDEPTH GAUGE FOR 2.0MM/2.4MM AND 2.7MM SCREWS
Type of DeviceGAUGE, DEPTH
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key8127082
MDR Text Key129152588
Report Number8030965-2018-58717
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.111.005
Device Lot Number9371442
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2019
Is This a Reprocessed and Reused Single-Use Device? No

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