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Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Injury (2348)
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Event Date 04/15/2020 |
Event Type
Injury
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Event Description
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"chronic flexion contracture of proximal interphalangeal joint treated with the compass hinge external fixator.A consecutive series of 27 cases".Author: s.Houshian et al., (british and european volume, 2002) 27b: 4: 356¿358.In this study, twenty-seven chronic flexion contractures of the proximal interphalangeal joint were treated with the compass hinge external fixator without open surgery.The fixator was removed after a mean of 33 (range, 14¿68) days.The mean time from injury to operation was 4 (range, 1¿19) years and all patients were reviewed at a mean follow-up of 21 (range, 12¿50) months.The mean extension gain was 381 (range, 0¿701), and the mean flexion¿extension arc improved by 421 (range, 0¿801).It was documented on the paper that superficial pin-track infections occurred in 11 cases, nine of these settled within 7 days with oral antibiotics and local wound care.
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Manufacturer Narrative
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Results of investigation: it was reported from a literature review that the patient presented superficial pin-track infection.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record, sterilization documentation and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore, no medical assessment can be performed at this time.Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.
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Search Alerts/Recalls
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