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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/ GAUGE,DEPTH

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SYNTHES GMBH DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/ GAUGE,DEPTH Back to Search Results
Catalog Number 03.010.019
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2021
Event Type  malfunction  
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Part: 03. 010. 019, lot: 3792059, manufacturing site: (b)(4), release to warehouse date: 21 june 2011. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. Visual inspection: the depth gauge f/lock-scr meas-range-110 f/ (p/n: 03. 010. 019, lot #: 3792059) was returned and received at us customer quality (cq). Upon visual inspection, it was observed that tip of the needle component was slightly bent. No other issues were identified. Functional test: a functional test was performed with the returned device. The device was functioning as intended and the device was also measuring as intended. Therefore, the reported condition of measuring short was not confirmed. Can the complaint be replicated with the returned device? no. Device failure/defect identified? yes. Dimensional inspection: dimensional analysis cannot be performed due to the geometry/design of the device. Document/specification review: the following documents were reviewed: current and manufactured. No design issues or discrepancies were identified. Complaint confirmed? no, the device was measuring and functioning as intended. Investigation conclusion: the complaint condition was not confirmed for the returned device. However, the tip of the needle was observed to be damaged on the device. No definitive root cause could be determined based on the provided information. The unintended forces might have contributed to the reported complaint condition. No new, unique or different patient harms were identified as a result of this evaluation. There was no indication that a design or manufacturing issue contributed to the complaint. No design issues were observed during the document/specification review. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the depth gauge appeared to measure 4-5mm short of what was actually being measured. The procedure was completed successfully with no delay. This report is for one (1) depth gauge. This is report 1 of 1 for (b)(4).
 
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Brand NameDEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/
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 Key11920936
MDR Text Key253747170
Report Number8030965-2021-04465
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.010.019
Device Lot Number3792059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2011
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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