One retaining 2.5mm hex drive r long (rhl2.5) was reported but not returned.However, the tapered screw-vent implant (tsv4h10) was returned for investigation.Visual evaluation of the as returned implant identified bone/blood residue around the external and internal thread due to usage but no apparent signs of malfunction.Functional testing could not be performed due to the nature of the devices and event.Pre-existing condition noted on the per was low bone density type iii.The reported implant was being placed on tooth # 30 (universal) when the incident occurred.X-r ay / picture images were not provided.Dhr review for the lot (1229004) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.However, dhr review could not be performed for the hex driver since the lot number was unknown.Complaint history review was performed for the lot (1229004) for similar events and no other complaint was identified.However, complaint history review could not be performed for the hex driver since the lot/item number was unknown.February post market trending was reviewed and there were no actionable events or corrective actions for the reported event or products.Therefore, based on the available information, implant malfunction did not occur.Additionally, driver malfunction and the reported event could not be verified since the driver was not returned.Based on the investigation, risk review and ifu, the most likely cause determined from the investigation is improper techniques used during placement or over use/mishandling causing wear.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
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