Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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It is noted that the customer shows possible lot of 022615b15, 041513d13, and 082412h12 for this item.However, the lot number could not be confirmed at this time.Because the lot number is unknown, the device history records could not be pulled and reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.This is report three of four for the same event.Reports one, two, and four are reported on mfr #0001032347-2016-00605.0001032347-2016-00606.And 0001032347-2016-00608.
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Event Description
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It is reported that this instrument's tip broke during a procedure.It is reported that all parts were retrieved and there was no foreign body in the patient.It is reported that the event did not lead to a delay of more than thirty minutes.
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.This is report three of four for the same event.Reports one, two, and four are reported on mfr #0001032347-2016-00605.0001032347-2016-00606.And 0001032347-2016-00608.
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Manufacturer Narrative
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The product was requested but not returned for evaluation; therefore, the complaint is non-verifiable.The most-likely, underlying cause could not be determined because the product was not returned and no functional tests could be performed.This is report three of nine for the same event.Reports one, two, four, and five through nine are reported on mfr #0001032347-2016-00605-2, 0001032347-2016-00606-2, 0001032347-2016-00608-2 and 0001032347-2016-00770 through 0001032347-2016-00774.Device not returned for evaluation.
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Search Alerts/Recalls
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