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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM CORTEX SCREW SELF-TAPPING 36MM; SCREW,FIXATION,BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM CORTEX SCREW SELF-TAPPING 36MM; SCREW,FIXATION,BONE Back to Search Results
Model Number 201.666
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Additional product code hrs.Initial reporter is synthes 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.
 
Event Description
It was reported that on an unknown date, the cortex screw was not received in the package.There was no patient involvement.This report is for one (1) 2.4mm cortex screw self-tapping 36mm.This is report 1 of 1 for (b)(4).
 
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Brand Name
2.4MM CORTEX SCREW SELF-TAPPING 36MM
Type of Device
SCREW,FIXATION,BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES GMBH
luzernstrasse 21
zuchwil 4528
SZ   4528
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8207857
MDR Text Key131771719
Report Number2939274-2019-55658
Device Sequence Number1
Product Code HWC
UDI-Device Identifier10886982142337
UDI-Public(01)10886982142337
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112583
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 12/07/2018
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 Number201.666
Device Catalogue Number201.666
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/07/2018
Initial Date FDA Received01/02/2019
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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