Model Number 216706 |
Device Problem
Material Separation (1562)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 04/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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No further information is available on the product at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
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Event Description
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Aspen surgical received a report from the end user indicating that a piece of a 1/2 circle taper point needle separated during a procedure.This report was filed in our complaint handling system as (b)(4).
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Manufacturer Narrative
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Aspen surgical received a report from the end user indicating that a piece of a 1/2 circle taper point needle separated during a procedure.The actual device was determined to be available for evaluation.The manufacturing lot number and photographic evidence was also provided for review.The end user indicated that the 1/2 circle taper point mayo needle broke during the process of passing sutures through the capsule and labrum of the left shoulder.The needle broke at the eye section.A piece remained in the patient.The surgeon was unable to retrieve the broken piece of needle using fluoroscopy.The needle was then located using a ct scan and the patient was taken back to surgery for successful retrieval of the retained needle part.The patient tolerated well and follow up care was not required.Analysis result of the finished good lot number 141805 and incoming inspections of the raw material were reviewed.All samples passed acceptance criteria.No non-conformance's were noted in the dhr.Two needles were returned.One needle was broken at the eye and the other needle was intact.The unbroken needle had clamp marks close to the midpoint of the needle.The broken needle had marks on the sides of the needle and not on the flat part of it.According to aspen surgical's ifu, the needles should not be clamped directly on the eye of the needle to the point and should be applied to the flat portion of the needle about 1/4 of the needle length from the eye end.A review of the samples returned show that the needles were clamped improperly either not on the flat side or too close to the eye or point, which likely caused them to break.Based on this information, the root cause is attributed to customer misuse and no further action is required.
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Event Description
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Aspen surgical received a report from the end user indicating that a piece of a 1/2 circle taper point needle separated during a procedure.This report was filed in our complaint handling system as complaint #(b)(4).
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Search Alerts/Recalls
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