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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE FOR SMALL SCREWS GAUGE, DEPTH

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SYNTHES GMBH DEPTH GAUGE FOR SMALL SCREWS GAUGE, DEPTH Back to Search Results
Catalog Number 319.090
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2021
Event Type  malfunction  
Manufacturer Narrative
Reporter is a synthes employee. Part #: 319. 090. Lot #: l731175. Manufacturing site: (b)(4). Release to warehouse date: 14 feb 2018. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. Customer quality investigation: the device was not returned. A photo-investigation was performed on the images. Upon inspecting the images provided, it was observed the needle component of the device was slightly bent. A functional assessment was not able to perform since the device was not returned. The complaint could not be confirmed for the reported condition, unable to assemble. However, the overall complaint could be confirmed for the bent condition. 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. Conclusion: the overall complaint can be confirmed during photo investigation. During the investigation, no product design issues, or discrepancies were observed. No manufacturing issues were noted during investigation. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Therefore, it has been determined that no corrective and/or preventive action is proposed. 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 sizer would not grip the cortex to measure and the stardrive was too worn to grip the screw. Concomitant device reported: unk - screw (part#: unknown, lot#: unknown, quantity: 1). This report is for (1) depth gauge for small screws. This is report 1 of 2 for (b)(4).
 
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Brand NameDEPTH GAUGE FOR SMALL SCREWS
Type of DeviceGAUGE, DEPTH
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12674730
MDR Text Key277721458
Report Number8030965-2021-08871
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number319.090
Device Lot NumberL731175
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/14/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/21/2021 Patient Sequence Number: 1
Treatment
SCRDRIVERSHAFT 3.5 T15; UNK - SCREWS: TRAUMA
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