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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PIN PULLER; EXTRACTION INSTRUMENTS

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DEPUY IRELAND - 9616671 ATTUNE PIN PULLER; EXTRACTION INSTRUMENTS Back to Search Results
Catalog Number 254500060
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2023
Event Type  malfunction  
Event Description
Surgeon noted that pin puller was jamming and not working appropriately within the surgery.The pin puller was removed from the surgery and replaced immediately with spare one from another loans kit.Surgical details, right side, tka.Procedure successfully completed with no surgical delay.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
 
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).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 :according to the information received, ¿surgeon noted that pin puller was jamming and not working appropriately within the surgery.The pin puller was removed from the surgery and replaced immediately with spare one from another loans kit.Team has removed from loan kit.Surgical details - -right side, tka¿.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection does not show any visual defect for attune pin puller.A dimensional inspection was not performed due to it is not applicable to the complaint condition.A functional test was performed and the pin jack handle open and closes correctly, no jammed condition is seen.The overall complaint was unconfirmed as the observed condition of the device would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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 corrected h3.
 
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Brand Name
ATTUNE PIN PULLER
Type of Device
EXTRACTION INSTRUMENTS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
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 Key17984853
MDR Text Key326261375
Report Number1818910-2023-21517
Device Sequence Number1
Product Code HWB
UDI-Device Identifier10603295130574
UDI-Public10603295130574
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
EXEMPT
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,Followup
Report Date 10/23/2023
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 Catalogue Number254500060
Device Lot NumberPG227735
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/18/2023
Initial Date FDA Received10/23/2023
Supplement Dates Manufacturer Received02/01/2024
02/26/2024
03/07/2024
Supplement Dates FDA Received02/01/2024
02/29/2024
03/07/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
ATTUNE PIN PULLER.
Patient SexMale
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