The acta orthopaedica belgica published (2016) "reduced length of stay with minimally invasive repair of ruptured achilles tendon".This study compared all cases of achilles tendon repair at the hospital, using open techniques and minimally invasive techniques with the achillon device, over a two year period.Length of stay and operating time was recorded, as were any complication rates, including tendon re-rupture.Post-operatively functional outcome questionnaires were sent to all patients.In total 39 patients underwent open repair and 26 underwent minimally invasive repair.Length of stay was significantly shorter in the minimally invasive group, with 58% of minimally invasive cases performed as a day case, compared to 31.1% of open cases.There was no difference in complication rates, including re-rupture, or functional outcome scores.Complications: complications included three (3) superficial wound infection and two (2) sural nerve injury in the minimally invasive group and three (3) superficial wound infection and three (3) sural nerve injury in the open repair group.The superficial wound infections all resolved with oral antibiotics and local wound care.Conclusions: treatment of achilles tendon rupture with a minimally invasive technique using the achillon device resulted in reduced length of hospital stay and an increased proportion of patients discharged on the same day following surgery, in comparison to standard open repair.There was however no difference in complication rates or post-operative functional outcome.
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As manufacturing lot number was not provided, no dhr review could be performed.As products were not returned, no failure analysis could be performed.As no dhr review or failure analysis was performed, root cause cannot be determined.However, there was a low risk that products involved in these complications did not provide the level of sterility intended and might be cause of wound infection.This risk could be mitigated by the fact that the seal defect impacted only the secondary package and medical staff had to check packaging integrity preoperatively.
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