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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA BL 1IN STABLECUT SYS 6; OTHER PRODUCTS
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DEPUY ORTHOPAEDICS INC US SIGMA BL 1IN STABLECUT SYS 6; OTHER PRODUCTS Back to Search Results
Model Number 562710601
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/24/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
It was reported that the pin fell out causing the screw to be loose.Saw blade was broken.No surgical delay happen.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
 
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Brand Name
SIGMA BL 1IN STABLECUT SYS 6
Common Device Name
OTHER PRODUCTS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8754203
Report Number1818910-2019-97511
Device Sequence Number16653935
Product Code GFA
UDI-Device Identifier00846795024186
UDI-Public00846795024186
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/13/2019
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
Operator of Device Health Professional
Device Model Number562710601
Device Catalogue Number562710601
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/13/2019
Supplement Date Received by Manufacturer05/27/2020
Initial Report FDA Received Date07/02/2019
Supplement Report FDA Received Date05/27/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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