(b)(4).Investigation summary: examination of the returned device did not confirm the reported cracking; however, the device is found broken into two pieces.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint sample consisted of (1) 254401006 attune femoral impactor, lot number au5895371.Examination of the returned device did not confirm the reported cracking; however, the device is found broken into two pieces.All pieces of the device were returned.The lot number au5895371 indicates that this device is from an annealed batch of impactors.Complaints databases searched on product code 254401006 identified previous complaints received for this failure mode.Expert opinion (refer (b)(4)) indicates that this failure mode is associated with environmental stress cracking (esc).The lot au5895371 of the attune femoral impactor is an annealed lot.While annealing helps in reducing the internal stress in the molded part, a complete reduction in internal stresses of the device is not achievable.There is a wide range of cleaning agents used across hospitals and it is possible that some result in greater degradation in the robustness of the device from repeated exposure.A pra ((b)(4)) held in sep, 2012 when a similar device (attune fb impactor- (b)(4)) either cracked or broke into large pieces did not identify a potential patient harm based on the nature of the failure.Post pra evaluation (held in september 2012); a new additional failure observation was made and showed that in some instances the attune impactors fractured (either completely or partially) and resulted in small fragments.This issue led to qrb ((b)(4)) initiation on october 2014 and recommended a field correction in the form of a communication to device users for all 3 attune impactors- rp, fb & fem.The field safety notice stresses to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure.There was no recommended field action other than this communication.Full lavage of the joint-space is recommended before and after implantation.Ifu 0902-00-836 contains wording relating to the importance of removing fragments from the surgical site.Both failure modes; patient harm & delay to surgery have been adequately covered in the risk assessment of the device and no further updates are required.The dfmea scores reflect the current failure rates of the device.However, in order to investigate the root cause and possibility of reducing this occurrence, capa-(b)(4) has been initiated and can be referenced for further details.Complaint trends will be monitored through (b)(4).Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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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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.Product complaint (b)(4).Investigation summary :examination of the returned device did not confirm the reported cracking; however, the device is found broken into two pieces.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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