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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS FEM A/P RESC GD LG; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

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DEPUY ORTHOPAEDICS INC US LCS FEM A/P RESC GD LG; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES Back to Search Results
Model Number 2287-35-000
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/10/2020
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 the fixation pin got stuck inside ap block.No surgical delay.
 
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.H10 additional narrative: 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 was unable to confirm the reported event.However, additional wear and damage to the overall device was found consistent with normal use and servicing.The investigation found no evidence of product malfunction or product error and the need for corrective action was not established.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: corrected: h3.
 
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Brand Name
LCS FEM A/P RESC GD LG
Type of Device
KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10555544
MDR Text Key207589408
Report Number1818910-2020-20503
Device Sequence Number1
Product Code HTZ
UDI-Device Identifier10603295110101
UDI-Public10603295110101
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 09/10/2020
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 Number2287-35-000
Device Catalogue Number228735000
Device Lot NumberAH0897F
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2020
Initial Date Manufacturer Received 09/10/2020
Initial Date FDA Received09/18/2020
Supplement Dates Manufacturer Received09/23/2020
10/01/2020
Supplement Dates FDA Received09/30/2020
10/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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