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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE NANOPASS REACH CRESCENT; PASSER
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STRYKER ENDOSCOPY-SAN JOSE NANOPASS REACH CRESCENT; PASSER Back to Search Results
Catalog Number CAT02298
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2023
Event Type  malfunction  
Event Description
It was reported that the device jaw broke during the procedure.The piece was retrieved.
 
Manufacturer Narrative
Alleged failure: piece of jaw from the nanopass broke off during labral repair.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) user technique related factors, 2) difficult anatomy, extremely tough soft tissue, 3) use of excessive force.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
 
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Brand Name
NANOPASS REACH CRESCENT
Type of Device
PASSER
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 Key18460682
MDR Text Key332738851
Report Number0002936485-2024-00017
Device Sequence Number1
Product Code HWQ
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 Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCAT02298
Device Lot NumberNOT REPORTED
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2023
Date Manufacturer Received12/11/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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