The device history record for the production batch associated with the complaint was reviewed to confirm that the products were supplied in conformance with ortho solutions specifications.The device history records for the batch confirmed that the products were manufactured to specification, conforming to both dimensional requirements and visual quality control that includes checks for the presence of burrs, sharp edges and inclusions.The raw material certificates were also reviewed to check the material grade, chemical composition and material hardness.The raw material was confirmed to be within specification, and the mechanical properties were above the minimum values required by bs en 10088-3 as specified on the material certificate.There were no deviations from specification and no concession was raised for this batch.Simulated use testing of the complaint batch was conducted using a 30pcf sawbone block which incorporated a 40pcf cortical layer representative of dense bone quality, to simulate a range of scenarios consisting of a range of entry angles, and a drilling depth which is beyond that which is typically observed in clinical use.Each drill bit sample was subject to four insertions.The test revealed no deficiency in the functionality or performance of the drill bits, and demonstrated that the drill bits were mechanically robust.As the complaint drill was discarded, no analysis of the device could be conducted, and no further information was provided regarding the clinical use of the product.Although the root cause could not be definitively ascertained, the investigation did not identify any deficiency or deviation with the drill bits.
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Patient underwent a shoulder stabilization procedure, whereby the drill bit was used.During the routine 4-week post-op check-up it was identified in the x-ray that there was a 1-2cm fragment of the drill bit retained in the patient.The patient was informed, and shown the x-ray.No adverse effects, injuries, or further complications were reported.
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