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Catalog Number 72201993 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/14/2018 |
Event Type
malfunction
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Event Description
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It was reported that during a shoulder stabilization the anchor broke in patient but was retrieved immediately and another was used.No significant delay or patient injury were reported.Back up device was available.
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Manufacturer Narrative
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One osteoraptor 2.3 mm suture anchor returned.The complaint stated: ¿the anchor broke in patient but was retrieved immediately¿.The insertion shaft device, suture and partial anchor were returned.There is no damage, bow or bending of the insertion shaft.The ultrabraid suture was returned attached to the handle.The anchor was attached to suture through the eyelet but no longer attached to the distal tip of the inserter.The anchor was severed.All but one barb is missing.The entire portion of anchor where the inserter seats into, is absent; approximately 0.200¿ of material.This condition is consistent with excess torque and potentially losing axial alignment.Instructions for use specifies: ¿breakage of the suture anchor can occur if the insertion site is not prepared with the recommended smith and nephew drill prior to implantation¿.A starter instrument is mandatory for this device¿s prep.This product recommends and specified drill bit, a 2.3 mm in line drill and a 2.3 mm obturator.These are purchased separately.No root cause related to the manufacturing of this device was established.
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Event Description
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It was reported that, during a shoulder stabilization, the anchor broke inside of the patient but was retrieved immediately and another one was used instead.No significant delay or patient injury were reported.
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Manufacturer Narrative
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One (b)(4) suturefix ultra device reported on.Due to unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were not possible without physical evaluation.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Note: when using osteoraptor 2.3 mm suture anchors, use a smith & nephew 2.3 mm in-line drill guide, 2.3 mm obturator, and a drill bit specific to the suture anchors to prepare the insertion site (each sold separately).Final product met specifications upon release to distribution.Lot number, unique identifier (udi) and expiration date added device manufacture date added.
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Search Alerts/Recalls
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