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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FRN ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FRN ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 03.033.001
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2018
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Initial reporter is synthes sales representative. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 (b)(6) 2018, after the successful completion of an intramedullary nailing of the right femur, the driving cap became cold-welded onto the radiolucent insertion handle and could no longer be taken apart. There was no patient consequence. This report is for one (1) radiolucent insertion handle frn. This is report 1 of 2 for (b)(4).
 
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Brand NameRADIOLUCENT INSERTION HANDLE FRN
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)
SYNTHES HAEGENDORF GMBH-CN
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8155873
MDR Text Key130327800
Report Number2939274-2018-55369
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172157
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,Followup
Report Date 11/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.033.001
Device Catalogue Number03.033.001
Device Lot NumberL551412
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2017
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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