SMITH & NEPHEW, INC. RAPTORMITE 3.0 PK W/NDL, 2 #0 ULTRABRA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72201806 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Subcutaneous Nodule (4548); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that after a repair ligament ankle with four(4) raptormite anchors ((b)(4) /lot #2080566); ((b)(4)/ lot#2065615); ((b)(4) /lot#2078872); ((b)(4)/ lot#2075624).The patient had an unspecified adverse reaction.It is unknown how the event was treated.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.The information provided states that the patient had an adverse event and was sent to an allergist but, there is no confirmation or enough information to determine the specific adverse event or the type of allergy presented.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Event Description
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It was reported that, after a repair ligament ankle with four (4) raptormite anchors ((b)(4) /lot #2080566); ((b)(4) / lot#2065615); ((b)(4) /lot#2078872); ((b)(4) / lot#2075624).The patient developed a sub cutaneous response around her two ankle incisions where the patient has two anchors placed on each side in association with a ligament reconstruction, then the patient developed a systemic response, that was worked up by an allergy an dermatology specialist who concluded it was a reaction to the peek anchors.It was requested to remove it, as per this, all the four anchor were removed.The patient appears to be doing better since their removal and the systemic response is now absent.
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Manufacturer Narrative
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H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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Search Alerts/Recalls
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