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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE VERTICAL SPAR, HIP DISTRACTOR APPARATUS, TRACTION, NON-POWERED

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STRYKER ENDOSCOPY-SAN JOSE VERTICAL SPAR, HIP DISTRACTOR APPARATUS, TRACTION, NON-POWERED Back to Search Results
Catalog Number 3105000103
Device Problem Mechanical Problem (1384)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2022
Event Type  malfunction  
Event Description
It was reported that there was loss of traction during the procedure.
 
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.
 
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Brand NameVERTICAL SPAR, HIP DISTRACTOR
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
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
andrea zenere
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key13546310
MDR Text Key288475794
Report Number0002936485-2022-00087
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3105000103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/24/2022
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

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