SMITH & NEPHEW, INC. HEALICOIL SA PK 4.5MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 72203378 |
Device Problem
Activation Problem (4042)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/28/2019 |
Event Type
malfunction
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Event Description
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It was reported that during the surgery the anchor was not deployed when it was inserted, there was a loss of tissue fixation.A backup device was used to complete the surgery.
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Manufacturer Narrative
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One 72203378 healicoil pk 4.5mm device was reported on.Due to product unavailability, the complaint could not be visually evaluated.Evaluation results were based upon information relayed.Factors that may affect device performance include: device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity that are unrelated to manufacture include: damaged or use of other than recommended prep instrument size or types.Pressure or excess torque applied.Inadequate bone quality resulting in anchor pullout or loss of fixation.Unexpected bone condition/density.Use of sharp instruments to manage or control the suture.If more torque is required to insert the anchor, stop and ensure that the hole size and depth are correct for the bone conditions encountered.It is the responsibility of the surgeon to determine the patient¿s bone condition, appropriately prepare the insertion site, and determine the suitability of the implant for the procedure.Breakage of the suture anchors can occur if insertion sites are not prepared with appropriate instrumentation prior to implantation.Use of excessive force during insertion can cause failure of the suture anchor or insertion device.A 3.8mm tapered awl is the recommended prep instrument for the 4.5mm suture anchor on normal bone applications.Product met specifications upon release to distribution.No further investigation is warranted at this time.
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Manufacturer Narrative
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One 72203378 healicoil pk suture anchor device used for treatment, was returned for evaluation.There was no relationship between the reported event and the device.The complaint stated: ¿the anchor was not deployed when it was inserted.¿ the insertion shaft showed no damage.Suture was removed from the anchor.It was not returned.The anchor was attached to the inserter tip.There was no observation of damage with the anchor or the inserter.The only observation was that the suture was no longer present.Per instructions for use: ¿breakage of the suture anchors can occur if insertion sites are not prepared with appropriate instrumentation prior to implantation.Excessive force during insertion can cause failure of the suture anchor or insertion device.A two-finger ao technique should be used to insert the anchor.If more torque is required to insert the anchor, stop and ensure that the drill bit size and depth are correct.Use of excessive force during insertion can cause failure of the suture anchor or insertion device.It is the responsibility of the surgeon to determine the patient¿s bone condition, appropriately prepare the insertion site, and determine the suitability of the implant for the procedure.¿ recommended prep instrument for normal bone condition is a 3.8mm tapered awl.Complaint history review found two other reports for this lot number.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.
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