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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DIST REAMER EXTENSION; RECLAIM INSTRUMENTS : ADAPTORS

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DEPUY IRELAND - 9616671 RECLAIM DIST REAMER EXTENSION; RECLAIM INSTRUMENTS : ADAPTORS Back to Search Results
Catalog Number 297500500
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2024
Event Type  malfunction  
Event Description
It was reported that white sleeve is missing spring.It did not happen in surgery.
 
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).Investigation summary it was reported that white sleeve is missing spring.It did not happen in surgery.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that there was no damage or defects with the reclaim dist reamer extension, the locking spring was on the device according to the drawing (dwg-297500500-component 2).The allegation cannot be confirmed.The overall complaint was not confirmed as the reclaim dist reamer extension was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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).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.
 
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Brand Name
RECLAIM DIST REAMER EXTENSION
Type of Device
RECLAIM INSTRUMENTS : ADAPTORS
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
3035526892
MDR Report Key18565333
MDR Text Key333501923
Report Number1818910-2024-01633
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295155911
UDI-Public10603295155911
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/23/2024
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 Number297500500
Device Lot NumberNB76768
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/17/2024
Initial Date FDA Received01/23/2024
Supplement Dates Manufacturer Received02/09/2024
03/15/2024
Supplement Dates FDA Received02/12/2024
03/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2014
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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