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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT GAUGE, DEPTH

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT GAUGE, DEPTH Back to Search Results
Model Number 03.113.025
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 an unknown date, during a procedure, the aiming arm for the locking compression (lcp) low bend medial distal tibia plate was not lining up with the plate properly. There was no surgical delay reported. The procedure was successfully completed. This report is for one (1) insertn handle f/3. 5mm low bnd medial distal tib plate/right. This is report 1 of 3 for complaint (b)(4).
 
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Brand NameINSERTN HANDLE F/3.5MM LOW BND MEDIAL DISTAL TIB PLATE/RIGHT
Type of DeviceGAUGE, DEPTH
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key11610360
MDR Text Key243729569
Report Number2939274-2021-01669
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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,Followup
Report Date 03/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.113.025
Device Catalogue Number03.113.025
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 Received04/19/2021
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? No
Type of Device Usage Unkown

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