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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP VOLAR DISTAL RADIUS PLATE EXTRA-ARTICULAR 4H HEAD-LEFT PLATE,FIXATION,BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP VOLAR DISTAL RADIUS PLATE EXTRA-ARTICULAR 4H HEAD-LEFT PLATE,FIXATION,BONE Back to Search Results
Model Number 242.467
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Reporter is jnj representative. 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 on an unknown date, the locking compression plate (lcp) volar distal radius plate was noticed bent, an unknown screw was not attaching correctly, two (2) unknown guide wires were very rough, tip of the screwdrivers were warped / bent from torque of insertion and the screwdriver handle was not picking up screws correctly as well. The issues were noticed during routine inspection. There was no patient involvement reported. This complaint involves nine (9) devices. This report is for (1) lcp® volar distal radius plate extra-articular 4h head-left. This is report 1 of 3 for (b)(4). Related product complaint: (b)(4).
 
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Brand NameLCP VOLAR DISTAL RADIUS PLATE EXTRA-ARTICULAR 4H HEAD-LEFT
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 Key10421333
MDR Text Key203365694
Report Number2939274-2020-03606
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091644
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
Report Date 07/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number242.467
Device Catalogue Number242.467
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 Received07/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/18/2020 Patient Sequence Number: 1
Treatment
CANNULATED 4.0MM HEXAGONAL SCREWDRIVER; STARDRIVE SCREWDRIVER SHAFT T8 105MM; STARDRIVE(TM) SCREWDRIVER T15; STDRV SCRWDR SFT SD6/SLF-RETING/2.0MM; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - SCREWS: TRAUMA
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