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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LARGE EX-FIX 11MM CRBN FBR ROD 600MM / MR-CONDITIONAL; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC LARGE EX-FIX 11MM CRBN FBR ROD 600MM / MR-CONDITIONAL; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Back to Search Results
Model Number 394.91
Device Problems Crack (1135); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional procode: ktt.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, the large ex-fix 11mm carbon fiber rod was chipping and cracking and unable to sterilize or assemble.There was no patient involvement.There is no further information available.This report is for (1) large ex-fix 11mm crbn fbr rod 600mm / mr-conditional.This is report 1 of 3 for (b)(4).
 
Manufacturer Narrative
Additional procode: ktt.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, the large ex-fix 11mm carbon fiber rod was chipping and cracking and unable to sterilize or assemble.There was no patient involvement.There is no further information available.This report is for (1) large ex-fix 11mm crbn fbr rod 600mm / mr-conditional.This is report 1 of 3 for (b)(4).
 
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Brand Name
LARGE EX-FIX 11MM CRBN FBR ROD 600MM / MR-CONDITIONAL
Type of Device
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13112837
MDR Text Key286057232
Report Number2939274-2021-07260
Device Sequence Number1
Product Code LXT
UDI-Device Identifier10886982199966
UDI-Public10886982199966
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number394.91
Device Catalogue Number394.91
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
LG EXFIX 11 CRBN FBR ROD 650 / MR-COND; LG EXFIX 11 CRBN FBR ROD 650 / MR-COND
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