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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS GAUGE, DEPTH

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SYNTHES GMBH DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS GAUGE, DEPTH Back to Search Results
Catalog Number 03.130.250
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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. The photo was returned to us cq for evaluation. The us cq team conducted a visual inspection of the returned device ((b)(6)). " visual analysis of the photo revealed that the tip of depth gauge f/scr ø1. 3-2 meas-range-43 is bent. No other defects were found with the device. As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed. As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications. The overall complaint was confirmed for depth gauge f/scr ø1. 3-2 meas-range-43. There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined. 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 history lot - a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. 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, the tip of the depth gauge was found bent prior to surgery. The bent tip was straightened and the depth gauge will be used in the procedure. This report is for one (1) depth gauge f/scr ø1. 3-2 meas-range-43. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameDEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS
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 Key13480520
MDR Text Key290795578
Report Number8030965-2022-00745
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.130.250
Device Lot NumberL002406
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2016
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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