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Catalog Number AR-4151DS |
Device Problems
Material Fragmentation (1261); Use of Device Problem (1670)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 06/06/2017 |
Event Type
Injury
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Manufacturer Narrative
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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.Device history record review revealed nothing relevant to this event.At this time, it cannot be determined how the device may have caused or contributed to the incident.An evaluation of the device cannot be performed as the device was discarded by the facility.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.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
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Event Description
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It was reported that the patient underwent a hammertoe repair procedure on her right fourth toe on (b)(6) 2017, using trim it pins.The pin did not perform as it should, and she had to do a second surgery on (b)(6) 2017 to remove the pin.No further details provided at time of initial report.Follow-up investigation from medical records: op report (b)(6) 2017 procedure: the patient implant was an ar-4151ds, implant delivery system, trim-it drill pin 1.5x 100 mm.Patient diagnosis which led to the (b)(6) 2017 procedure was right fourth digit hammertoe.Patient (b)(6) at time of revision.(b)(6) lbs.Height (b)(6) inches, (b)(6).Op report (b)(6) 2017 procedure: on (b)(6) 2017 patient underwent a revision surgery due to painful retained internal fixative, deep right 4th digit.Extensive dissection was needed to remove the trim-it pin.It was necessary to cut the trim-it pin at the level of the distal interphalangeal joint and then it was removed proximally and distally.The proximal portion was found to be in an odd shape and one portion was found to be in a u shape.The second small fragment was removed distally and the entire piece measured 3 cm which was felt to be the entire length of the trim-it pin.Surgeon office records dated (b)(6) 2017: patient reported non-compliance at follow up visit four days post op (b)(6) 2017 procedure.Patient reported walking without her prescribed shoe at night to the bathroom.
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Search Alerts/Recalls
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