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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 SIGMA HP UNI TIB CUT BLK LM/RL KNEE INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS, INC.1818910 SIGMA HP UNI TIB CUT BLK LM/RL KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 202440100
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Examination of the returned device confirmed the reported event. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
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 pin broke off in tibial resection guide and had remained in pin driver. Rep wasn't informed by sterile processing until aug 07, 2017. Lots will be given once rep picks up instruments.
 
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Brand NameSIGMA HP UNI TIB CUT BLK LM/RL
Type of DeviceKNEE INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6845645
MDR Text Key105811717
Report Number1818910-2017-24063
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number202440100
Device Lot NumberSO2017275
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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