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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. 2.5 X 30MM PIP DART, PEEK, 10 DEGREE; PIN, FIXATION, SMOOTH
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ARTHREX, INC. 2.5 X 30MM PIP DART, PEEK, 10 DEGREE; PIN, FIXATION, SMOOTH Back to Search Results
Catalog Number AR-4154P-3010
Device Problems Break (1069); Fitting Problem (2183)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/16/2016
Event Type  Injury  
Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.At this time, it cannot be determined how the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Device history record review revealed nothing relevant to this event.This is the (b)(4) complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device requested but not yet received.
 
Event Description
It was reported that the surgeon drilled a hole in the bone with the associated drill and inserted the anchor.Anchor did not fit in hole and surgeon pulled the anchor back.Anchor broke and a piece of the anchor remained in patient's bone.Surgeon removed the fragment by expanding the hole with a drill.Surgery was successfully finished using the remaining part of the dart.
 
Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This is a follow-up submission to reflect device evaluation.At this time, it cannot be determined how the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
 
Event Description
It was reported that the surgeon drilled a hole in the bone with the associated drill and inserted the anchor.Anchor did not fit in hole and surgeon pulled the anchor back.Anchor broke and a piece of the anchor remained in patient's bone.Surgeon removed the fragment by expanding the hole with a drill.Surgery was successfully finished using the remaining part of the dart.
 
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Brand Name
2.5 X 30MM PIP DART, PEEK, 10 DEGREE
Type of Device
PIN, FIXATION, SMOOTH
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath, sr mdr analyst
1370 creekside boulevard
naples, FL 34108-1945
8009337001
MDR Report Key6278838
MDR Text Key65783174
Report Number1220246-2017-00001
Device Sequence Number1
Product Code HTY
UDI-Device Identifier00888867102439
UDI-Public00888867102439
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K141577
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 02/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/01/2021
Device Catalogue NumberAR-4154P-3010
Device Lot Number10049094
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received01/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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