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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE PERF L105 TAN ROD,FIXATION,INTRAMEDULLARY

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SYNTHES GMBH TFNA HELICAL BLADE PERF L105 TAN ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.405S
Device Problem Difficult to Advance (2920)
Patient Problem No Code Available (3191)
Event Date 10/25/2020
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Additional product code ktt. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. (b)(4). 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
Device report from india reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for a tfna surgery. During the surgery, after reaming for the blade was done , the blade was inserted, and it got stuck before getting completely inserted. Blade neither moved forward nor the blade got removed using the removal instruments. Finally, the portion of the blade which was protruding out laterally was cut by the surgeon. While hammering the spiral blade over the guide wire it got stuck in between and neither was it going in nor was it coming out in spite of repeated attempts. It was almost cold welded with the nail. The surgery was completed successfully with 60-90 minutes delay. It was unknown if fragments were removed without any additional intervention. The patient outcome was unknown. Concomitant device reported: unknown nail insertion handles (part#: unknown, lot#: unknown, quantity: 1). Unknown drill (part#: unknown, lot#: unknown, quantity: 1). Unknown hammer/mallet (part#: unknown, lot#: unknown, quantity: 1). Unknown aiming arm (part#: unknown, lot#: unknown, quantity: 1). This complaint involves three (3) devices. This report is for (1) tfna helical blade perf l105 tan. This is report 1 of 3 for (b)(4).
 
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Brand NameTFNA HELICAL BLADE PERF L105 TAN
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10869320
MDR Text Key217438568
Report Number8030965-2020-09072
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.405S
Device Lot Number10L6593
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 Received12/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/19/2020 Patient Sequence Number: 1
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