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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN POLY EXTRACTOR; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

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DEPUY ORTHOPAEDICS INC US PINN POLY EXTRACTOR; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS Back to Search Results
Model Number 2217-50-001
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2022
Event Type  malfunction  
Event Description
It was reported that the liner extractor not working.Bar not sliding or moving when wheel is turned.Could not remove liner during revision.Back up plan was screw used to remove liner.There was a five minute surgical delay.
 
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this complaint was not returned.Photo evidence provided was reviewed and found no visible damage that could confirm a device issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation mre was not performed.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary the device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned device found the tip of the device bent.However, the functional test was unable to replicate the reported condition.The reported condition was not confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a date code was provided, which indicates that the device was manufactured on 12/10.A manufacturing records evaluation (mre) was not performed since a valid finished good lot number was not provided for this device.
 
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Brand Name
PINN POLY EXTRACTOR
Type of Device
HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key15666212
MDR Text Key304791133
Report Number1818910-2022-21255
Device Sequence Number1
Product Code HWB
UDI-Device Identifier10603295098928
UDI-Public10603295098928
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/25/2022
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 Number2217-50-001
Device Catalogue Number221750001
Device Lot NumberJ1210
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/11/2022
Initial Date FDA Received10/25/2022
Supplement Dates Manufacturer Received11/30/2022
02/10/2023
Supplement Dates FDA Received12/02/2022
02/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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