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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE RECESS 42MM; NAIL,FIXATION,BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE RECESS 42MM; NAIL,FIXATION,BONE Back to Search Results
Model Number 212.118
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Additional product code ktt.Complainant part is not expected to be returned for manufacturer review/investigation.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 product was received; 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 that on an unknown date, during open reduction internal fixation (orif) lt distal tibia fracture the surgeon remarked 3.5 locking screw 42mm and 3.5 locking screw 44mm would not lock into medial distal tibia plate.The surgeon left all three implants in the patient.There was a surgical delay of ten minutes.The patient outcome was good.This complaint involves three (3) devices.This report is for (1) 3.5mm locking screw slf-tpng w/stardrive recess 42mm.This is report 2 of 3 for (b)(4).
 
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Brand Name
3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE RECESS 42MM
Type of Device
NAIL,FIXATION,BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10627655
MDR Text Key209811938
Report Number2939274-2020-04486
Device Sequence Number1
Product Code JDS
UDI-Device Identifier10886982151926
UDI-Public(01)10886982151926
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072095
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number212.118
Device Catalogue Number212.118
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/12/2020
Initial Date FDA Received10/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age51 YR
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