The handle with quick coupling, small (p/n 311.43 lot 7363916) was received with a vertical crack on the handle.The crack was across the location of the dowel pin and measured approximately 25.71 mm in length (calipers ca802).The instrument/handle was not separated into two pieces.No other issues were identified with the returned components of the device.A dimensional inspection was not performed during this investigation as the root cause of the device condition has been identified as a device design deficiency, which has subsequently been addressed through capa (b)(4).The reported complaint condition of broken is confirmed for the handle with quick coupling, small (p/n 311.43 lot 7363916) as the instrument was received with a vertical crack on the handle.The crack was across the location of the dowel pin and measured approximately 25.71 mm in length (calipers ca802).A valid design defect was identified as the root cause of the cracked condition.Was launched to address the design defect and was closed on (b)(6) 2017 after effectiveness monitoring of the design changes was deemed effective.No manufacturing issues were identified through the investigation.A corrective and/or preventative action has already been launched and completed to address the design deficiency.See related action.Based upon these findings, no additional corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot : part # 311.43.Synthes lot number: 7363916.Manufacturing site: synthes (b)(4).Release to warehouse date: 02-may-2013.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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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It was reported that on an unknown date, during a routine incoming inspection of loaner set at minor kings mountain, field stock location (fsl), the small handle with quick coupling was broken.There was no known hospital or patient involvement.This report is for one (1) handle with quick coupling, small.This is report 1 of 1 for (b)(4).
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