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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 Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 09/28/2020
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
During impaction of the pinnacle cup, the end plate of the handle broke of.The cup was well fixed, so he incident didn't have any impact on the operation or patient.They used the broken handle to impact the liner into the cup.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.Depuy-synthes 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.
 
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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 Key10682723
MDR Text Key211441678
Report Number1818910-2020-22334
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 foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 09/29/2020
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 NumberSO2043028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2020
Initial Date Manufacturer Received 09/29/2020
Initial Date FDA Received10/15/2020
Supplement Dates Manufacturer Received10/15/2020
10/30/2020
Supplement Dates FDA Received10/27/2020
11/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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