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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SONIC CONTROL SERRATED AGGRESSIVE KNIFE, UNIVERSAL; INSTRUMENT, ULTRASONIC SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO SONIC CONTROL SERRATED AGGRESSIVE KNIFE, UNIVERSAL; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Catalog Number 5450815114
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/21/2020
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 during visual inspection.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 reported product involved with this event was returned for evaluation and the reported failure of a hair in the sealed pack was confirmed.The event reported that the product was not used, no patient involvement and no adverse consequences were reported.This product and lot number was manufactured by synergetics on 10-sep-2019.Manufacturing of this product has now transferred to stryker freiburg.Synergetics no longer manufacture this product.Raising a nc with synergetics at this time provides no value to synergetics or stryker processes.No further action is required at this time.
 
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 during visual inspection.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
SONIC CONTROL SERRATED AGGRESSIVE KNIFE, UNIVERSAL
Type of Device
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10550596
MDR Text Key207515492
Report Number0001811755-2020-02411
Device Sequence Number1
Product Code LFL
UDI-Device Identifier37613252518403
UDI-Public37613252518403
Combination Product (y/n)N
PMA/PMN Number
K020220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5450815114
Device Lot NumberM0025915
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2020
Date Manufacturer Received11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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