MAUDE Adverse Event Report: ARTHREX, INC. 2.5 X 30MM PIP DART, PEEK, 10 DEGREE; PIN, FIXATION, SMOOTH

Catalog Number	AR-4154P-3010
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/16/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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.

• Brand Name: 2.5 X 30MM PIP DART, PEEK, 10 DEGREE
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6278838
• Report Number: 1220246-2017-00001
• Device Sequence Number: 1075668
• Product Code: HTY
• UDI-Device Identifier: 00888867102439
• UDI-Public: 00888867102439
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141577
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2021
• Device Catalogue Number: AR-4154P-3010
• Device Lot Number: 10049094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2017
• Supplement Report FDA Received Date: 02/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other