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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AIR MENISCUS SYSTEM, CURVED; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

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STRYKER ENDOSCOPY-SAN JOSE AIR MENISCUS SYSTEM, CURVED; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE Back to Search Results
Model Number 4720
Device Problems Problem with Sterilization (1596); Tear, Rip or Hole in Device Packaging (2385)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2021
Event Type  malfunction  
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 there was a breach in the sterile barrier.
 
Event Description
It was reported that there was a breach in the sterile barrier.
 
Manufacturer Narrative
Alleged failure: it was reported that when opening supplies for the or case the customer noted that the foil packaging for a sterile air meniscal repair device had a puncture in the upper corner.The case was completed using a different unit.The probable root causes could be: severe shipping conditions or user mishandling.The device manufacture date is not known.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
 
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Brand Name
AIR MENISCUS SYSTEM, CURVED
Type of Device
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key11373691
MDR Text Key234641419
Report Number0002936485-2021-00110
Device Sequence Number1
Product Code GAT
UDI-Device Identifier07613327375404
UDI-Public07613327375404
Combination Product (y/n)N
PMA/PMN Number
K153087
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4720
Device Catalogue Number4720
Device Lot Number7004435
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2021
Date Manufacturer Received01/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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