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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK SAW BLADE
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DEPUY ORTHOPAEDICS INC US UNK SAW BLADE Back to Search Results
Catalog Number UNK SAW BLADE
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 10/26/2020
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 patient had under went left total knee arthroplasty.During patella resection, the blade hit the cutting guide & broke the tip of the blade.This added approximately five minutes to the cases, finding the blade & opening a new blade.All pieces were found.This account has had multiple reports of the blades breaking during total procedures.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
 
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Brand Name
UNK SAW BLADE
Type of Device
SAW BLADE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10816697
MDR Text Key217654920
Report Number1818910-2020-24314
Device Sequence Number1
Product Code HAB
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 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK SAW BLADE
Was Device Available for Evaluation? No
Date Manufacturer Received12/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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