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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB CUT BLK LM/RL; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

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DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB CUT BLK LM/RL; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES Back to Search Results
Model Number 2024-40-100
Device Problems Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/05/2020
Event Type  malfunction  
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 Description
It was reported that during the case while using the sigma uni tibia cutting block, the threaded headed pin became stuck inside the cutting block.The surgery time was not extended because the surgeon could still make his cut using the tibia cutting block.
 
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 : examination of the returned device confirmed the reported event.A fixation pin was stuck in one of the pin holes of the cutting block.Furthermore, the head of the shaft was broken.The need for corrective action is not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H6 (component code): part/component/sub-assembly term not applicable (g07001) is being utilized to capture mechanical jam (a0506).
 
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Brand Name
SIGMA HP UNI TIB CUT BLK LM/RL
Type of Device
KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10705259
MDR Text Key212103273
Report Number1818910-2020-22838
Device Sequence Number1
Product Code HTZ
UDI-Device Identifier10603295082972
UDI-Public10603295082972
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
Report Date 10/05/2020
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 Number2024-40-100
Device Catalogue Number202440100
Device Lot NumberA1208
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2020
Initial Date Manufacturer Received 10/05/2020
Initial Date FDA Received10/20/2020
Supplement Dates Manufacturer Received11/12/2020
11/30/2020
Supplement Dates FDA Received11/20/2020
11/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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