Model Number 2545-00-060 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problems
Not Applicable (3189); No Code Available (3191)
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Event Date 07/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that an attune pin puller won't grab pins, an attune tibial drill was missing depth stop holding ball and an attune tibial impactor broke into two pieces.There was a 5 minutes surgical delay reported.All broken pieces were retrieved from the patient.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: examination of the returned device was unable to confirm the reported event.The investigation found no evidence of product malfunction or product error and the need for corrective action was not established.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: corrected: h3, h6 (patient).H6 patient code: no code available (3191) was used to capture prolonged surgery and insufficient information.
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Search Alerts/Recalls
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