Complaint from (b)(6).Business unit: depuy synthes hip and knee.Date j&j became aware: 30/04/2018.Date of event: (b)(6) 2018.Name of reporter: (b)(6).Hospital: (b)(6).Product name: attune patella clamp.Product code: 2545-01-041.Lot/batch/exp: d254501041.Was the product being used in a clinical trial? no.Did the event happen during a procedure? yes.Were you in the procedure at the time of the event? no.Event outcome/how was it managed? anatomic patella press button wouldn¿t stay in place on the patella clamp.Surgeon held on place by hand whilst cement set.Was there any consequence to the patient due to the event? no.Was the surgery prolonged due to the event? if yes, confirm how many minutes delay: 5min.Has the reporter facility indicated there may be legal action? no.Is the product available for return? yes.Please give a detailed explanation of the event: during the cementing stage of the patella, professor uses the anatomic patella button (2545-05-550 and 2545-05-552), the patella button holder wouldn¿t engage onto the clamp resulting in the button sliding off the clamp.The professor held the patella button by hand on the clamp whilst engaging the clamp to the definitive patella implant.On inspection of the instruments.The patella clamp itself is missing the mechanism to hold the button in place.
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Product complaint #: (b)(4).Investigation summary: the instrument associated with this report was not returned.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will 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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