OBERDORF SYNTHES PRODUKTIONS GMBH QUICK COUPLING HANDLE WITH SWIVEL CAP; MISC, SURGICAL, ORTHO, INSTRUMENT
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Catalog Number 324.107 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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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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Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure during preparation for the surgery the instrument appeared to have to debris on it, which required the instruments to be re-sterilized.The surgery was delayed.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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) 2019, right before the surgery, when the nurse set up the reported handle with drill bit, the nurse recognizes that there was a fair fiber like foreign material that was adhered to the bottom of the handle.Thus, all equipment including the reported devices had to be sterilized again.As the results, the surgery was postponed.Patient involvement was unknown.Concomitant device reported: unknown drill bit (part#unknown, lot#unknown, quantity 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
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Manufacturer Narrative
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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.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.Additional information: d11: concomitant device received: drill bit with stop, 2-flute, for quick coupling (part #: 388.394, lot #: unknown, quantity: 1).Investigation summary : product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.
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