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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ROD FOR REAMING GUIDE HOLDER
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DEPUY ORTHOPAEDICS INC US ROD FOR REAMING GUIDE HOLDER Back to Search Results
Model Number 2307-74-002
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2021
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 upon removal of the proximal reaming guide holder internal rod after use, the rod appears to be slightly bent causing it to stick a bit and to not slide smoothly per the tech.The instrument was used without any issues and there was no delay to the case.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device confirmed the reported bent condition which would prevent assembly with a mating device.The investigation findings did not indicate that a broader investigation or corrective action was necessary.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.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).Where the product and lot code was provided, 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.
 
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.
 
Event Description
Additional information was received indicated that there were no pieces broken from the instrument.
 
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Brand Name
ROD FOR REAMING GUIDE HOLDER
Type of Device
REAMING GUIDE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11815929
MDR Text Key250329815
Report Number1818910-2021-10157
Device Sequence Number1
Product Code HSD
UDI-Device Identifier10603295116134
UDI-Public10603295116134
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,Followup,Followup
Report Date 05/04/2021
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 Number2307-74-002
Device Catalogue Number230774002
Device Lot Number5292909
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2021
Initial Date Manufacturer Received 05/04/2021
Initial Date FDA Received05/12/2021
Supplement Dates Manufacturer Received05/12/2021
06/07/2021
06/25/2021
Supplement Dates FDA Received05/28/2021
06/21/2021
06/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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