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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW EXTRACTOR ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW EXTRACTOR ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 03.037.030
Device Problem Device-Device Incompatibility (2919)
Patient Problems Not Applicable (3189); No Code Available (3191)
Event Date 12/20/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(4). 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 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 that on (b)(6) 2019, in attempting to remove a previously implanted trochanteric fixation nail advanced (tfna), the surgeon was unable to get the lag screw removal device to lodge into the lag screw, so he was unable to remove the unknown screw. Surgery was stopped and implant was left in place. Patient might need further surgery. No fragments generated. There was a 45 minutes surgical delay. Procedure was not completed. There was patient consequence. This complaint involves two (2) devices. This report is 1 of 2 for (b)(4).
 
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Brand NameHELICAL BLADE/SCREW EXTRACTOR
Type of DeviceROD, FIXATION, INTRAMEDULLARY
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 Key9604531
MDR Text Key189310010
Report Number2939274-2020-00284
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.030
Device Catalogue Number03.037.030
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 Received02/14/2020
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: 01/17/2020 Patient Sequence Number: 1
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