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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: TFNA ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH UNK - NAILS: TFNA ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 10/25/2020
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - nails: tfna/unknown lot. Part and lot numbers are unknown; udi 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. 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) unk - nails: tfna. This is report 3 of 3 for (b)(4).
 
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Brand NameUNK - NAILS: TFNA
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10869327
MDR Text Key217438367
Report Number8030965-2020-09076
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

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