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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN POLY IMPACTOR TIP 36MM; HIP INSTRUMENTS : INSERTION DEVICES
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DEPUY ORTHOPAEDICS INC US PINN POLY IMPACTOR TIP 36MM; HIP INSTRUMENTS : INSERTION DEVICES Back to Search Results
Model Number 2217-50-008
Device Problems Loose or Intermittent Connection (1371); Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/25/2020
Event Type  malfunction  
Manufacturer Narrative
(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
It was reported that the metal collar on the pinnacle 36 mm liner impactor spins around when you tighten it.No further information was available.No surgical delay.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary :the instrument associated with this report was not returned.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.H10 additional narrative: corrected: h6 (device code).The previous reported device code unintended movement is being corrected to more appropriate coding which is loose or intermittent connection.
 
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Brand Name
PINN POLY IMPACTOR TIP 36MM
Type of Device
HIP INSTRUMENTS : INSERTION DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10254542
MDR Text Key198309903
Report Number1818910-2020-15477
Device Sequence Number1
Product Code HWA
UDI-Device Identifier10603295098973
UDI-Public10603295098973
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2217-50-008
Device Catalogue Number221750008
Was Device Available for Evaluation? No
Date Manufacturer Received08/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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