DEPUY ORTHOPAEDICS INC US GLO ADV CENTER/PERIPH BIT; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
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Catalog Number 212861007 |
Device Problems
Dull, Blunt (2407); Material Twisted/Bent (2981); Naturally Worn (2988); Scratched Material (3020)
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Patient Problem
Not Applicable (3189)
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Event Date 03/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/ explanted.
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Event Description
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It was reported that the surgeon recognized that the frill tip was dull because the surgeon could not perform drilling (with drill guide (p/n and lot number were unknown)) to open the bone hole to implant the glenoid component into the patient¿s body during tsa surgery.The surgeon tried to open the bone hole without drill guide, however, the surgeon could not open the bone hole again.The surgery was completed by using alternative drill tip (p/n and lot number were unknown).There was less than 30mi.Surgical delay and no harm to the patient.No further information was provided by the hospital.
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Manufacturer Narrative
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(b)(4).Investigation summary = > no products were returned for investigation.However, we did receive an initial investigation report from japan that had photographs of the three products that confirmed the drill product was dull and showed signs of excessive wear.The complaint was found to be unjustified.The reason that the drill could not drill was down to excessive wear and tear.The ifu does state that the products should be visually checked prior to use for wear.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision depuy synthes 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.Product complaint # (b)(4).No products were returned for investigation.However, we did receive an initial investigation report from japan that had photographs of the three products that confirmed the drill product was dull and showed signs of excessive wear.The complaint was found to be unjustified.The reason that the drill could not drill was down to excessive wear and tear.The ifu does state that the products should be visually checked prior to use for wear.No corrective action is required.Addendum added 02-september-19.Following receipt of the complaint products, the products were inspected and general wear of the drill bit was confirmed.It was concluded that: based on the information received and the investigation performed, the most likely cause of the complaint is instrument dulling over time from repeated use.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up 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.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.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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