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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW INSERTER ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW INSERTER ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 03.037.025
Device Problems Use of Device Problem (1670); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. A review of the device history records has been requested. Device was used for treatment, not diagnosis.
 
Event Description
It was reported on (b)(6) 2018, during a resident in service, while the sales consultant was putting the screw inserter into an unknown insertion handle, something was bent. The devices were not connecting easily. There was no patient involvement. This complaint involves two (2) devices. This report is 1 of 2 for (b)(4).
 
Manufacturer Narrative
The device was received, the investigation is in progress, 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.
 
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Brand NameSCREW INSERTER
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8122590
MDR Text Key129039383
Report Number2939274-2018-55228
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup,Followup
Report Date 11/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.025
Device Catalogue Number03.037.025
Device Lot Number9850516
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2019
Is This a Reprocessed and Reused Single-Use Device? No

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