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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE F/SCR Ø4.5-6.5 MEAS-RANGE UP GAUGE, DEPTH

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SYNTHES GMBH DEPTH GAUGE F/SCR Ø4.5-6.5 MEAS-RANGE UP GAUGE, DEPTH Back to Search Results
Catalog Number 319.100
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/07/2022
Event Type  malfunction  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that (b)(6) 2022, the depth gauge f/scr ø4. 5-6. 5, 319. 100 was bent and appears fragile. The surgeon not willing to use and risk breakage within patient. Procedure was completed successfully with five(5) minutes delay. No fragments generated. This report is for one (1) depth gauge f/scr ø4. 5-6. 5 meas-range up. This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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. 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 F/SCR Ø4.5-6.5 MEAS-RANGE UP
Type of DeviceGAUGE, DEPTH
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13451342
MDR Text Key290540071
Report Number8030965-2022-00701
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,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number319.100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2022
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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