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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP STANDARD 8CM; SPLINT, INTRANASAL SEPTAL
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP STANDARD 8CM; SPLINT, INTRANASAL SEPTAL Back to Search Results
Catalog Number 5400010008ITL
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2021
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
 
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.It was further reported there was a minimal delay to get a replacement product.
 
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.It was further reported there was a minimal delay to get a replacement product.
 
Manufacturer Narrative
H6: the quality investigation is complete.
 
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Brand Name
STANDARD 8CM
Type of Device
SPLINT, INTRANASAL SEPTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key11938110
MDR Text Key257761434
Report Number3015967359-2021-01045
Device Sequence Number1
Product Code LYA
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5400010008ITL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2021
Date Manufacturer Received09/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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