• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that the pinnacle cup impactor broke when impacting the cup.No surgical delay.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10643484
MDR Text Key210255889
Report Number1818910-2020-21723
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,health
Type of Report Initial,Followup
Report Date 09/22/2020
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 NumberSO2037883
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2020
Initial Date Manufacturer Received 09/22/2020
Initial Date FDA Received10/07/2020
Supplement Dates Manufacturer Received10/20/2020
Supplement Dates FDA Received10/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-