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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 03.010.428
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2022
Event Type  malfunction  
Event Description
Device report from synthes (b)(6) reports an event as follows: it was reported it looked like the plastic material of the instrument has started to melt. This was discovered during inspection of the loan kit. This report is for a depth gauge. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Initial reporter is a synthes employee. 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 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)
WERK BALSTHAL (CH)
dornacherstrasse 20
balsthal 4710
SZ 4710
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13827351
MDR Text Key288780020
Report Number8030965-2022-01739
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.010.428
Device Lot Number9898691
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2016
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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