STRYKER GMBH DRILL SLEEVE, LOCKING Ø3.1MM, SHORT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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Model Number 705004 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/23/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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As reported: "when drilling through the locking sleeve, after drilling the front cortex, a strange sound was heard and the drill could not be pulled out.When the entire sleeve was pulled out, the drill came out with it, but the drill could not be pulled out of the sleeve.".
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Event Description
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As reported: "when drilling through the locking sleeve, after drilling the front cortex, a strange sound was heard and the drill could not be pulled out.When the entire sleeve was pulled out, the drill came out with it, but the drill could not be pulled out of the sleeve.".
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Manufacturer Narrative
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The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received drill sleeve show signs of extensive usage.Dents, hitting marks, and scratches are visible all over the outer surface.The distal opening near the thread region is also found deformed along with the threads.Minimal clearance and repeated relative surface motion have led to fretting.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, with the extent of damage, it can be ascertained that the root cause of the issue is user related.The drill getting stuck inside the sleeve is a direct result of excessive friction between the drill and the sleeve due to a potential misalignment during use, leading to fretting.If any further information is provided, the complaint report will be updated.
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