Correction: this a correction mdr for initial mdr mfg report#: 2023988-2016-00017 was submitted under incorrect integra lifesciences (b)(4) on 06/14/2016.Integra has completed their internal investigation on 26 jul 2016.The investigation included: methods: -evaluation of actual device -review of device history records -review of complaint history results: evaluation of device: engineering and quality were able to confirm the customer complaint.During the inspection, there were two skull pins that had some type of foreign material stuck on their surfaces, and there was one skull pin with a piece of hair found inside the sterilized pouch.Device history record reviewed for this product id lot #: 1160076 manufactured on match 03, 2016 show no abnormalities related to the reported failure.A total of 1800 pouches (150 cases with 12 pouches each) were manufactured and all passed required inspection points with no associated mrr¿s, variances or rework.No service history is on file for the returned items.A two year lookback in trackwise for this reported failure and or related to "contamination" for this product family shows that no additional complaints were received.No new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: engineering and quality were able to verify the customer complaints.The root cause to the hair strand found inside the sterilized pouch may have occurred during the sterilization process.The skull pins with the contaminants/foreign material on their surfaces cannot be 100% attributed at this time as there is no certainty as to what stage of the manufacturing process (from assembly to sterilization) this may have occurred.Furthermore, these two skull pins were sent out to get analyzed at a lab.This is an isolated incident and will be monitored for trending.
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This is the second of two reports (same product id, similar product problem, same lot number and same distributor).Linked to mfg report: 3004608878-2016-00209.During the inspection of incoming goods, the distributor found a hair was mixed into the inside of the package of the a1072 mayfield disposable adult skull pins.There was no patient contact or injury.
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