One 72203981 healicoil pk 4.5mm suture anchor used for treatment, was not returned for evaluation.Due to product unavailability, the complaint could not be visually evaluated.If objective evidence, relevant information, packaging or product becomes available, the complaint will certainly be revisited.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: 1.Damaged or use of other than recommended prep instrument size or types.2.Pressure or excess torque applied.3.Inadequate bone quality resulting in anchor pullout or loss of fixation.4.Unexpected bone condition/density.5.Breakage and damage can occur due to 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.Recommended prep instrument for the 4.5mm anchor used on normal bone condition is a 3.8mm tapered awl.Product met specifications upon release to distribution.Complaint history review found no other report for this lot.
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