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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM FOR IM NAILS ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM FOR IM NAILS ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.005.418
Device Problem Migration (4003)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Additional product code: hwc synthes sales representative. 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. The investigation could not be completed; no conclusion could be drawn, as no product was received. The investigation could not be completed; no conclusion could be drawn. 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. 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) 2018, the patient underwent a removal/revision of damaged titanium locking screws in the tibia nail on an unknown date. It was further reported, the titanium locking screw may have migrated and was removed and replaced with a longer screw. The unknown locking screw was broken and a piece was retained, another screw was placed. It is unknown if there was surgical delay. Patient outcome is unknown. Procedure was successfully completed. Concomitant device reported: unknown tibial nail (part# unknown, lot# unknown, quantity# 1). This complaint involves two (2) devices. This report is 1 of 2 for (b)(4).
 
Manufacturer Narrative
Reporter is a synthes employee. Additional information provided. 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.
 
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Brand Name4.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM FOR IM NAILS
Type of DeviceROD,FIXATION,INTRAMEDULLARY
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 Key8130308
MDR Text Key129299467
Report Number2939274-2018-55256
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.005.418
Device Catalogue Number04.005.418
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/04/2018 Patient Sequence Number: 1
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