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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 ELEMENTS: TFNA HELICAL BLADE ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Event year is reported as 2021; however exact date of event is unknown. This report is for an unk - nail head elements: tfna helical blade/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received. Reporter is a j&j representative. 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 product was received; 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 unknown date, patient underwent for a procedure. During the procedure, the aiming arm "hooks" both snapped off, and the drill bit was hitting the nail through the triple sleeves. It is unknown if the procedure was successfully completed. Patient status is unknown. This complaint involves (5) devices. This report is for (1) unk - nail head elements: tfna helical blade. This report is 4 of 5 for (b)(4).
 
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Brand NameUNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12509015
MDR Text Key272569197
Report Number2939274-2021-05682
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received08/24/2021
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

Patient Treatment Data
Date Received: 09/21/2021 Patient Sequence Number: 1
Treatment
AIMING ARM/ RADIOLUCENT; INSERTION HANDLE/ RADIOLUCENT MEDIUM; UNK - DRILL BITS: TRAUMA; UNK - GUIDES/SLEEVES/AIMING: SLEEVE
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