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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN STRAIGHT CUP IMPACTOR; HIP INSTRUMENTS : IMPACTORS

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DEPUY ORTHOPAEDICS INC US PINN STRAIGHT CUP IMPACTOR; HIP INSTRUMENTS : IMPACTORS Back to Search Results
Model Number 2217-50-041
Device Problem Break (1069)
Patient Problem Not Applicable (3189)
Event Date 01/10/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
The tip of the cup impactor wasn't lining up with the 36 head.When looking closer the end piece end of the cup impactor was falling off.Surgery delayed by 10 minutes.Second case was opened.
 
Manufacturer Narrative
Product complaint # (b)(4).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.Added: b5.
 
Event Description
Additional information received indicated that nothing fell in the patient.As the impactor was being assembled to the 36mm head, they noticed it wasn¿t screwing together.From there they noticed the impactor itself has fallen apart, but this was before it made it away from the sterile table, so it wasn¿t near the patient.
 
Manufacturer Narrative
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 the examination of the returned instrument confirmed the complaint.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.Device history lot null device history batch null device history review null 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.
 
Manufacturer Narrative
Product complaint # : (b)(4).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.
 
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Brand Name
PINN STRAIGHT CUP IMPACTOR
Type of Device
HIP INSTRUMENTS : IMPACTORS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key9627698
MDR Text Key189343234
Report Number1818910-2020-02818
Device Sequence Number1
Product Code MRA
UDI-Device Identifier10603295098980
UDI-Public10603295098980
Combination Product (y/n)N
PMA/PMN Number
P070026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 01/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2217-50-041
Device Catalogue Number221750041
Device Lot NumberNT0808
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2020
Initial Date Manufacturer Received 01/10/2020
Initial Date FDA Received01/24/2020
Supplement Dates Manufacturer Received01/21/2020
03/09/2020
04/01/2020
Supplement Dates FDA Received02/13/2020
03/17/2020
04/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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