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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIBIA PLATE/LEFT GAUGE,DEPTH

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIBIA PLATE/LEFT GAUGE,DEPTH Back to Search Results
Model Number 03.113.026
Device Problem Patient Device Interaction Problem (4001)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Synthes rep. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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 on (b)(6) 2019, one (1) insertion handle for low bend medial tibial plate right was missing the connecting screw or the aiming arm. It was also mentioned that the rad tech tried to remove the connecting screw from one (1) insertion handle for low bend medial tibial plate which was the left one trying to put it in the right one and upon the connecting screw was cross-threaded with the insertion handle. Lastly, one (1) star drive screwdriver was damaged while trying to remove the connecting screw. There was no patient involvement. This complaint involves two (2) devices. This report is 2 of 2 for (b)(4).
 
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Brand NameINSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIBIA PLATE/LEFT
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 HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8843680
MDR Text Key152912446
Report Number2939274-2019-59459
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,Followup
Report Date 07/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.113.026
Device Catalogue Number03.113.026
Device Lot Number3606182
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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