OBERDORF SYNTHES PRODUKTIONS GMBH TAP FOR 3.5MM CANCELLOUS BONE SCREWS/50MM CALIBRATION; TAP, BONE
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Model Number 311.349 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is company representative.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.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 a tap for a bone screw snapped and broke intraoperatively while in use, during an unknown procedure on (b)(6) 2020.The surgeon was easily able to remove the device from the patient.Additionally, the surgeon reported screws loosening when inserting screws and noted that two locking caps cross threaded upon insertion.The screws were then replaced with two more.The procedure was completed sucessfully with no surgical delay.Concomitant device reported: unknown screwdriver (part# unknown, lot# unknown, quantity 1).This is report 1 of 4 for (b)(4).
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Event Description
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While inserting all 4 screws, the surgeon felt that they were loosening.Once inserted, the screws were secure and the procedure was continued.
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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.
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