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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 7MM FEMORAL INDEX GUIDE; ACCESSORIES, ARTHROSCOPIC

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STRYKER ENDOSCOPY-SAN JOSE 7MM FEMORAL INDEX GUIDE; ACCESSORIES, ARTHROSCOPIC Back to Search Results
Model Number 234-500-205
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 09/29/2022
Event Type  Injury  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
 
Event Description
It was reported that the device broke and it was unable to be removed from the patient.
 
Manufacturer Narrative
Risk file does not have a risk line specifying allegation.An nc 3279144 is created for this.Manufacture date is not known.H3 other text : 81.
 
Event Description
It was reported that the device broke and it was unable to be removed from the patient.
 
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Brand Name
7MM FEMORAL INDEX GUIDE
Type of Device
ACCESSORIES, ARTHROSCOPIC
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer (Section G)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer Contact
lucas wolski
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key16390539
MDR Text Key309730333
Report Number0002936485-2023-00130
Device Sequence Number1
Product Code NBH
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number234-500-205
Device Catalogue Number234-500-205
Device Lot Number131437
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/20/2023
Initial Date FDA Received02/16/2023
Supplement Dates Manufacturer Received01/20/2023
Supplement Dates FDA Received07/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age17 YR
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