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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA LOCKING SCREW STARDRIVE 8MM SCREW, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA LOCKING SCREW STARDRIVE 8MM SCREW, FIXATION, BONE Back to Search Results
Catalog Number 02.210.108
Device Problem Unintended Movement (3026)
Patient Problems Failure of Implant (1924); Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

Date of infection and device migration is not known. This report is for two (2) unknown cortical screws/unknown lot. Part and lot numbers are unknown; udi number is unknown. 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. 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 a hardware removal and revision surgery was performed on (b)(6) 2018. The initial surgery was performed on (b)(6) 2018 for an open reduction and internal fixation of the distal radius. The hardware removal was due to two (2) 2. 7mm proximal cortical screws backing out of the bone. During the surgery there was a lot of fluid in the wound indicating a possible infection. Five cultures were taken to see if an infection is present but results are not yet available. The hardware that was removed was one (1) 2. 4mm variable angle locking compression plate (va-lcp) 2 column volar distal radius plate, five (5) 1. 8mm buttress screws, one (1) 2. 4mm cortical locking screw, and two (2) 2. 7mm cortical screws. All parts were intact with no malfunctions. Patient was revised to a dorsal spanning plate and six (6) 2. 7mm locking screws. There were no surgical delays, x-rays are not available, surgery was completed successfully and patient outcome was stable. This is report 4 of 4 for (b)(4).

 
Manufacturer Narrative

Additional product code: hrs. Without a lot number the device history records review could not be completed. Subject device has been received and is currently in the evaluation process. 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

This report is for one (1) 2. 4mm va locking screw. This is report 4 of 9 for (b)(4).

 
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Brand Name2.4MM VA LOCKING SCREW STARDRIVE 8MM
Type of DeviceSCREW, 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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7290560
MDR Text Key100755419
Report Number2939274-2018-50745
Device Sequence Number1
Product Code HWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK103243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 01/29/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number02.210.108
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/08/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 02/22/2018 Patient Sequence Number: 1
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