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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR SMALL SCREWS GAUGE, DEPTH

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR SMALL SCREWS GAUGE, DEPTH Back to Search Results
Model Number 319.09
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The repair technician reported the tip of the depth gauge is missing. Missing parts is the reason for repair. The cause of the issue is missing parts. The following parts were replaced: tip of depth gauge. The item was repaired per the inspection sheet, passed synthes final inspection on (b)(6) 2020 and will be returned to the customer upon completion of the service and repair process. The evaluation was confirmed. The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed. Device history lot: part #: 319. 090, lot #: 2263678 (us lot 5554772), manufacturing site: (b)(4), release to warehouse date: 12. Apr. 2007. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's 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
It was reported that on an unknown date, during routine incoming inspection of a loaner set, it was observed that the depth gauge was missing a piece. There was no known patient or hospital involvement. This report is for one (1) depth gauge for small screws. This is report 1 of 1 for (b)(4).
 
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Brand NameDEPTH GAUGE FOR SMALL SCREWS
Type of DeviceGAUGE, DEPTH
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10387245
MDR Text Key202588909
Report Number2939274-2020-03439
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number319.09
Device Catalogue Number319.09
Device Lot Number5554772
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2007
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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