STRYKER GMBH TRANSPORT STRUT HOFFMANN LRF; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Model Number 4933-0-400 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that there was a bifocal bone transport due to a septic tibia fracture previously treated with two plates.The resection was around 9 cm and the surgeon decided to do two osteotomies.For this reason six bone transport rods were used.After the positioning of the frame, the length needed to be corrected, however, when the the distal locking components were unlocked, (with red washers) they were not able to be locked again.This resulted in a 45 minute delay to the surgery.This was the first surgery with external fixator but not the first one for the patient.The patient was previously treated with two plates, which were removed due to septic pseudoarthrosis.After a resection the external fixator was applied for bone transport procedure.No problem for the patient until now.
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
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Manufacturer Narrative
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The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.Engineering reviewed the received information and noted: i can confirm that the three mentioned lot¿s (h32791 / h66392 / k36312) are in scope of the nc.A nc got launched as at the lower end of the bone transport strut the function is not given, inspection of the received information/evidences are done or will be done, in the proceedings of the nc.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Event Description
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It was reported that there was a bifocal bone transport due to a septic tibia fracture previously treated with two plates.The resection was around 9 cm and the surgeon decided to do two osteotomies.For this reason six bone transport rods were used.After the positioning of the frame, the length needed to be corrected, however, when the the distal locking components were unlocked, (with red washers) they were not able to be locked again.This resulted in a 45 minute delay to the surgery.This was the first surgery with external fixator but not the first one for the patient.The patient was previously treated with two plates, which were removed due to septic pseudoarthrosis.After a resection the external fixator was applied for bone transport procedure.No problem for the patient until now.
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Manufacturer Narrative
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Recall number added to h9.
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Event Description
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It was reported that there was a bifocal bone transport due to a septic tibia fracture previously treated with two plates.The resection was around 9 cm and the surgeon decided to do two osteotomies.For this reason six bone transport rods were used.After the positioning of the frame, the length needed to be corrected, however, when the the distal locking components were unlocked, (with red washers) they were not able to be locked again.This resulted in a 45 minute delay to the surgery.This was the first surgery with external fixator but not the first one for the patient.The patient was previously treated with two plates, which were removed due to septic pseudoarthrosis.After a resection the external fixator was applied for bone transport procedure.No problem for the patient until now.
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Search Alerts/Recalls
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