If the information is unknown, not available or does not apply, the section/field of the form is left blank.Reporter is a synthes employee.Part: 03.211.005, lot: t948737, manufacturing site: (b)(4), release to warehouse date: september 27, 2010.A review of the device history records was performed for the finished device lot number, and no non-conformance's were identified.Visual inspection: the 2.4/2.7mm va-lcp bending plier was received at us customer quality (cq).Visual inspection of the complaint device showed the compression springs part 329_146_9 and 329_146_8 were deformed.Functional test: during the functional assessment, compression was applied to both handles by squeezing them but not locking them.After release of the grip to unload the compression, the handles did not retract back to their resting position.The functional test failed.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Also, measurement of relevant parts of the device would require the device to be disassembled.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the springs of the device were found deformed.No root cause could definitively be determined for the reported complaint condition.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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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