Catalog Number 309.25 |
Device Problems
Defective Device (2588); Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.If additional information is made available, the investigation will be updated as applicable.Device history lot: part #: 309.25; lot #: 8708114; manufacturing site: (b)(4); release to warehouse date: 18 nov 2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent revision surgery to remove tcp implants.In the revision surgery, the 2.7mm locking screw broke during removal.When removing the broken locking screw remaining in the bone, the surgeon scraped around the locking screw with the 2.7mm hollow reamer and used the 2.7mm extraction bolt, but the bolt and the locking screw did not engage well.Eventually, the broken locking screw was removed.The surgery was completed within 30 minutes delay.The patient condition was stable.On (b)(6) 2020, the patient underwent open reduction internal fixation surgery treating distal radius with tcp implants.This complaint involves one (1) device.This report is for (1) hollow reamer-complete for 2.7mm screws.This report is 3 of 3 for (b)(4).
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Search Alerts/Recalls
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