SMITH & NEPHEW ORTHOPAEDICS LTD BHR CURVED CUP INTRODUCER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Model Number 90128257 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/17/2021 |
Event Type
Injury
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Event Description
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It was reported that, during a thr surgery, the bhr curved cup introducer broke internal to patient.The piece that the alignment guide attaches to broke off while pounding to the bhr cup in.The procedure was successfully completed without delay and it was unknown how the procedure was completed.No patient injury or other complications were reported.
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Manufacturer Narrative
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H3, h6: a bhr curved introducer (part: 90128257, lot: s0703056) was returned for inspection after reporting that the instrument broke during surgery.It was reported that the piece that the alignment guide attaches to broke off while pounding the bhr cup during the procedure.No adverse affects, delays or patient harm was reported.A visual inspection was performed, the product quality was checked and confirmed.Laser markings were slightly faded but fully legible and correct.The product is non functional due to part broken and weakened structure.The part has been seen to be snapped off the device.Damage can be seen showing product misuse in addition to impact damage on the head consistent with surgical use.The threads are acceptable.A review of the complaint history for the bhr curved cup introducer was performed using part & batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the batch.Due to the age of the instrument, and as the manufacturer is out of business, the production records could not be retrieved or reviewed for the instrument reportedly involved in this incident.However, all the released instruments involved would have met manufacturing specifications at the time of production.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.Based on the available information and the returned instrument the probable root cause of this issue are unintentional user error caused by the impactor being hit in the wrong place.If further information is received then the complaint will be reopened and investigated.Based on this investigation, the need for corrective and preventative action is not indicated.The instrument will be retained at aurora uk as it cannot be repaired.
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