Medical product: blunt tip screw, 4x65mm; item#47248606540; lot#3010693; blunt tip screw, 4x38mm; item#47248603840; lot#3064862; blunt tip screw, 4x36mm; item#47248603640; lot#3068457; proximal humerus, right, 11x160mm; item#47249616011; lot#3045138 cortical bone screw, 4x26mm; item# 47248612640; lot#3054456; cortical bone screw, 4x28mm; item#47248612840; lot#3054458; proximal humerus nail cap, 0mm; item#47248801000; lot#3073821 the manufacturer did not received x-rays or any other source documents for review.
Lot numbers were received and the device history record were reviewed and found to be conforming.
The investigation of the case and the process of gaining necessary information is still ongoing.
A cause for this specific event cannot be ascertained from the information provided.
As soon as supplemental information becomes available an updated report will be submitted.
Zimmer biomet¿s reference number of this file is (b)(4).
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