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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 18 HOLES 241MM; PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 18 HOLES 241MM; PLATE, FIXATION, BONE Back to Search Results
Model Number 223.671
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that on an unknown date in 2022, during post op inspection it was identified that depth gauges were stiff and don't slide and the locking compression plate has stripped locking hole.There was no know patient involvement.This report is for one (1) 3.5mm lcp plate 18 holes 241mm.This is report 5 of 5 for complaint (b)(4).
 
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional device product codes: hwc, ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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.
 
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Brand Name
3.5MM LCP PLATE 18 HOLES 241MM
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
BRANDYWINE
1303 goshen parkway
west chester PA 19380
Manufacturer Contact
kate karberg
1302 wrights lane east
west chester, PA 19380
8472871282
MDR Report Key14014115
MDR Text Key289212279
Report Number2939274-2022-01195
Device Sequence Number1
Product Code HRS
UDI-Device Identifier10886982158116
UDI-Public(01)10886982158116
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082807
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
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 Number223.671
Device Catalogue Number223.671
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/07/2022
Initial Date FDA Received04/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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