Catalog Number 227456000 |
Device Problems
Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Not Applicable (3189)
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Event Date 08/06/2019 |
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 the drill bit (p/n: 227456000) and the drill shaft (p/n: 227452000) were able to join during the tha surgery of the patient¿s left hip joint on (b)(6) 2019 however the lock did not function and could not be fixed even if the shaft was turned to the lock position.The surgery was completed within a 30 minutes surgical delay and there was no adverse consequence to the patient.No further information is available.
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Manufacturer Narrative
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This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.Product complaint #: (b)(4).Investigation summary: examination of the returned instrument found no defect with the instrument.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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Manufacturer Narrative
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Product complaint#: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Corrected : h6.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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Search Alerts/Recalls
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