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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).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in 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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6: reviewing attached picture, the complaint description can be confirmed the tfna blade is cut and the blade tip is implanted at the x-ray visible.Just based on the picture it is not possible to confirm a functional issue, therefore the complaint is rated as n/a in the confirmed field.Product was not returned.Based on the information available, it has been determined that no corrective and 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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in 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.
 
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Brand Name
UNK - NAILS: TFNA
Type of Device
ROD, 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 Physician
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/25/2020
Initial Date FDA Received11/19/2020
Supplement Dates Manufacturer Received11/19/2020
12/17/2020
03/10/2022
Supplement Dates FDA Received11/30/2020
01/12/2021
03/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
TFNA HELICAL BLADE PERF L105 TAN; UNK - DRILL; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - NAIL INSERTION HANDLES
Patient Outcome(s) Required Intervention;
Patient Age62 YR
Patient SexMale
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