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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FORTE EAR CLYLINDER; SPLINT, INTRANASAL SEPTAL
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STRYKER INSTRUMENTS-KALAMAZOO FORTE EAR CLYLINDER; SPLINT, INTRANASAL SEPTAL Back to Search Results
Catalog Number ND04-011/02 C
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2020
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
 
Event Description
It was reported that there was a potential sterility breach on the packaging of the device, it was noted that there was a hair in the pack prior to a surgical procedure.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
 
Manufacturer Narrative
H6; the product and packaging reported involved in this event were returned for evaluation.On receipt of the product a hair/fiber was observed sealed within the product packaging blister seal area.The product was evaluated by the product packaging engineer who concluded that where the product did show that a hair / fiber was sealed within the packaging seal edge no evidence was observed of a sterility breach.The seal integrity is preserved.No product malfunction was observed.The root cause of this event is undetermined.
 
Event Description
It was reported that there was a potential sterility breach on the packaging of the device, it was noted that there was a hair in the pack prior to a surgical procedure.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
 
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Brand Name
FORTE EAR CLYLINDER
Type of Device
SPLINT, INTRANASAL SEPTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10570180
MDR Text Key208108481
Report Number0001811755-2020-02455
Device Sequence Number1
Product Code LYA
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberND04-011/02 C
Device Lot NumberEDA2018112913
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2020
Date Manufacturer Received11/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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