Additional narrative: patient date of birth and weight were not provided for reporting.Event occurred intraoperative on (b)(6) 2017.Device was not implanted/explanted.(b)(4).Device history records review was completed for part# 282.611, lot# 5061320.Manufacturing location: (b)(4), manufacturing date: sep 15, 2005.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformances or rework noted.Product development investigation was completed.A visual inspection, functional test (technique guide review) and drawing review were performed as part of this investigation.The complaint condition is confirmed.The helix blade and the side plate were received stuck together.The returned instruments were examined by customer quality upon receipt.Relevant drawings were reviewed.The outer diameter (od) of the barrel of the side plate was measured as 14.01mm (specification: 14 +0.10/-0.05mm).Helix blade length as well as side plate id could not be measured the devices are stuck together.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.Synthes technique guide for lcp dhhs system was reviewed.It says ¿do not use the cap for impactor and shaft guide to seat the plate if the plate is more than 5 mm off the bone.If the plate appears to be more than 5 mm off the bone, the flats on the helix blade and the internal flats on the key may not be properly aligned.Impacting the plate in this condition could cause further unwanted advancement of the helix blade.¿ additionally it says ¿use of light blows with the hammer is recommended until the side plate is seated completely against the lateral cortex.¿ it is possible that not following any of the above two technique instruction could have led to the complaint condition.The exact root cause could not be determined in this case.It is possible that the user did not follow the user instructions/technique guide which could have led to the complaint condition.There is no evidence of a manufacturing issue and no product design issues or discrepancies were observed that may have contributed to the 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 a patient underwent an unknown procedure on (b)(6) 2017.When the surgeon attempted to seat the barrel over the blade with the impactor, the blade advanced through the patient's femoral head and became stuck inside the dynamic helical hip system (dhhs) barrel.There was a delay of 30 to 45 minutes to complete the surgery.The surgeon attached the threaded extractor from the dhhs set and used a slotted hammer to remove the blade.Since it was stuck, the blade and barrel had to come out as a unit.Another blade with the same part number was used to complete the rest of the surgery successfully and without further issues.The patient's status was stable.No additional information available.Concomitant device reported: impactor (part # unknown, lot # unknown, quantity 1).This report is for one (1) 135 deg lcp® dhhs(tm) sideplate-std barrel 3 holes.(b)(4).
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