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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 456.322S
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that on an unknown date, the tfna nail did not assemble properly. The surgeon used another nail to complete the procedure. No surgical delay reported. It is unknown if the procedure successfully completed. No patient consequence reported. This report is for one (1) 12mm/130 deg ti cann troch fixation nail 170mm-sterile this is report 1 of 3 for (b)(4).
 
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Additional narrative: initial reporter is synthes sales representative. This report is for an unknown screw/unknown lot. Part and lot numbers are unknown; udi number is unknown. 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.
 
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Brand Name12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13443895
MDR Text Key285955366
Report Number2939274-2022-00348
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011857
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number456.322S
Device Lot NumberH469687
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/09/2017
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/03/2022 Patient Sequence Number: 1
Treatment
UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: NAIL DISTAL LOCKING
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