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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE 2.7/3.5 0-60 GAUGE, DEPTH

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SYNTHES GMBH DEPTH GAUGE 2.7/3.5 0-60 GAUGE, DEPTH Back to Search Results
Catalog Number 03.133.080
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that a sales rep was informed yesterday of a damaged depth gauge from the universal small fragment set (03. 133. 080). There was no patient involvement or delay to surgery and the product is not available to be sent back. This complaint involves one (1) device depth gauge 2. 7/3. 5 0-60.
 
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j sales representative. 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. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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.
 
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Brand NameDEPTH GAUGE 2.7/3.5 0-60
Type of DeviceGAUGE, DEPTH
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14161276
MDR Text Key289684486
Report Number8030965-2022-02572
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.133.080
Was Device Available for Evaluation? No
Date Manufacturer Received03/24/2022
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

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