STRYKER GMBH SAFETY CLIP (BONE TRANSPORT STRUT) 14 X 12 X 5MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Catalog Number 49330401 |
Device Problems
Detachment Of Device Component (1104); Nonstandard Device (1420)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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The reported event that safety clip (bone transport strut) 14 x 12 x 5 mm was alleged of 'component loosened' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.However, a manufacturing nc has been raised to address a manufacturing deviation.Therefore, in term of goodwill, a credit note will be provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.The product had fallen off and was not recovered.
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Event Description
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It was reported that doctor notified the rep that "every patient" we put a bone transport hoffman lrf frame on had a least one of our safety clips fall off.Rep reported no patient adverse consequences.Additional clips were added.
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Manufacturer Narrative
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The reported event that safety clip (bone transport strut) 14 x 12 x 5mm was alleged of 'component loosened' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.However, a manufacturing nc has been raised to address a manufacturing deviation.Therefore, in term of goodwill, a credit note will be provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.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 doctor notified the rep that "every patient" we put a bone transport hoffman lrf frame on had a least one of our safety clips fall off.Rep reported no patient adverse consequences.Additional clips were added.
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Search Alerts/Recalls
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