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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LCP WRIST FUSION STANDARD BEND PLATE PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LCP WRIST FUSION STANDARD BEND PLATE PLATE, FIXATION, BONE Back to Search Results
Model Number 04.110.150
Device Problem Migration (4003)
Patient Problems Arthritis (1723); Swelling (2091); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Without a lot number the device history records review could not be completed. Product was not returned. 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 that on (b)(6) 2019, patient underwent removal of one (1) titanium locking compression plate (lcp) wrist fusion standard bend plate and eight (8) unknown locking screws. There was a failure of the locking screws over the 3rd metacarpal. The screws had failed at the head shaft junction. The metal plate had lifted itself off the 3rd metacarpal and was prominent over the dorsal aspect of the right hand and four (4) unknown locking screws were broken. Extensive adhesions were present between the subcutaneous tissues and extensor tendons. A swelling and prominence were noted over the dorsal aspect of the 3rd metacarpal where the lcp standard bend plate had disengaged from the 3rd metacarpal. There was no surgical delay. Procedure outcome was successful. Patient status is unknown. Concomitant device reported: unknown locking screws (part #: unknown, lot #: unknown, quantity #: 4). This is report 1 of 5 for (b)(4).
 
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Brand NameTI LCP WRIST FUSION STANDARD BEND PLATE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8884258
MDR Text Key154003403
Report Number2939274-2019-59709
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042355
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.110.150
Device Catalogue Number04.110.150
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2019
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: 08/12/2019 Patient Sequence Number: 1
Treatment
UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
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