Catalog Number 199721000S |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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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The following was reported: product code: 1997-21-000s and 1997-21-001s.Lot/batch/exp: has some blood on these; thus, cannot see the lot numbers.Please clean and refer to items.Did the event happen during a procedure? yes.Were you in the procedure at the time of the event? yes.Was the product being used in a clinical trial? no.Event outcome/how was it managed? discussion had with no further action.Was there a patient impact or was the procedure extended greater than 30 minutes due to the failure? no.Has the reporter facility indicated there may be legal action? no.Is the product available for return? yes but this has not been decontaminated.Please give a detailed explanation of the event: mr (b)(6) was using a cocr rod to correct the concavity.The rod was seated fully in the head of the screw.All other nuts were locked down but he had missed one, as he inserted a correction key into the extended tabs.However, it began to crossthread.I am unsure why the extended tab splayed as the rod was fully seated.I said to use a quick stick the second time but he ignored this and tried again with another unitised and it crossthreaded again.The third time he used a quick stick and this worked successfully without crossthreading.He was very frustrated as a result and said he shouldn¿t need to use a quick stick when rod is seated in the head of the screw.
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Manufacturer Narrative
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Product complaint # = > (b)(4) visual examination found that the threads on the set screw are torn.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.With the information provided, a definitive root cause for the torn threads on the set screw cannot be determined.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.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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