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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEM: TFN LAG SCREW ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEM: TFN LAG SCREW ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number UNK - NAIL HEAD ELEM: TFN LAG
Device Problem Device-Device Incompatibility (2919)
Patient Problem Not Applicable (3189)
Event Type  malfunction  
Manufacturer Narrative
Product complaint#: (b)(4). This report is for an unknown - nail head elem: tfn lag screw/unknown lot number. Without the specific part number, the udi number and 510k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number, the device history records review could not be completed as no product was received. Investigation summary: product was not returned. Based on the information available, it has been determined that no corrective and preventive action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. 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 surgeon could not insert the unknown lag screw into the unknown titanium trochanteric fixation nail (tfn) nail. There was a surgical delay. The procedure was successfully completed. The patient outcome was fine. This complaint involves two devices. This report is for one unk - nail head elem: tfn lag screw. This report is 2 of 2 for (b)(4).
 
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Brand NameUNK - NAIL HEAD ELEM: TFN LAG SCREW
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9895009
MDR Text Key185541420
Report Number2939274-2020-01577
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK - NAIL HEAD ELEM: TFN LAG
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 Received02/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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