The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.
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The manufacturer became aware of a pmcf published by klinikum aschaffenburg ¿ alzenau, in germany.The title of this report is ¿a post-market clinical follow-up (pmcf) of the treatment of hand and wrist fractures with the stryker hand plating system¿ which is associated with the stryker ¿ variax hand locking and profyle standard¿ system.This report includes research done on 105 patients between the period may, 2019 and april, 2020.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses material failure with breakage of all 3 plates and significant callus formation followed by revision surgery.The report states: ¿p.18.38 was a (b)(6) man who suffered fractures to metacarpals ii, iii, and iv due to a severe blow to his right hand (ao: 77.2.2 b, 77.3.2 a, 77.4.2 a).Metacarpal ii was a i° open fracture.The treatment was carried out using one variax m stryker plate each (i.E.A total of 3) and wound debridement.The follow-up treatment was released as usual by means of free, passive physiotherapy without load for a total of 6 weeks.Because of the open fracture situation, antibiotic therapy with cefuroxime 500 mg was administered twice daily for a total of 10 days.In the course of the treatment, the patient presented with persistent complaints and swelling.An x-ray examination showed a material failure with breakage of all 3 plates and significant callus formation.A revision and renewed osteosynthesis with unknown plates were performed.100 days later, with the help of an exogenous ultrasound therapy, the patient regained complete finger extension and fist closure.¿.
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