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.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: initial reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part # 398.752, lot # 13-3272, manufacturing site: (b)(4), release to warehouse date: 30 jan 2014, supplier: leitner ag, expiration date: n/a.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.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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Device report from japan reports an event as follows: it was reported that on an unknown date, the patient underwent the surgery with the products in question.During the operation check of the equipment, the connection between the main unit and various arms of the sliding reduction clamp in question could not be connected because the connection part of the main unit and the various arms did not fit.The diameter of the body side of the connection part and the diameter of the arm side did not seem to match in the first place.There are three types of arms, but all three have mismatched diameters and cannot be connected to the main unit.No further information is available.This report is for a hohmann-style arm 183mm.This is report 2 of 4 for (b)(4).
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