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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH ENDOTRAC ECTR STERILE HOOK BLADE; ARTHROSCOPE
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STRYKER GMBH ENDOTRAC ECTR STERILE HOOK BLADE; ARTHROSCOPE Back to Search Results
Catalog Number 2055
Device Problems Nonstandard Device (1420); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/06/2017
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device was disposed.
 
Event Description
It was reported that when opening a blade whose packaging identified the product as a (b)(4) carpal tunnel hook blade, the device inside was a 3054 triangular blade.Rep reported a lot code of aaac784 but could not identify whether that was on the packaging or the device.Rep reported that there was no harm to the patient, exact nature of the procedure is unknown.
 
Manufacturer Narrative
Remedial action initiated (recall) was entered in error.
 
Event Description
It was reported that when opening a blade whose packaging identified the product as a # 2055 carpal tunnel hook blade, the device inside was a 3054 triangular blade.Rep reported a lot code of aaac784 but could not identify whether that was on the packaging or the device.Rep reported that there was no harm to the patient, exact nature of the procedure is unknown.
 
Event Description
It was reported that when opening a blade whose packaging identified the product as a # 2055 carpal tunnel hook blade, the device inside was a 3054 triangular blade.Rep reported a lot code of aaac784 but could not identify whether that was on the packaging or the device.Rep reported that there was no harm to the patient, exact nature of the procedure is unknown.
 
Manufacturer Narrative
The reported event that the device was alleged of a mix up could not be confirmed, since the device was not returned and no other evidence was provided.However a similar situation has already been identified therefore the supplier has been contacted to conduct an investigation on this event.A review of the device history records for the reported finished good lots and raw material components identified no quality issues during the incoming, manufacturing, in process or final inspection processes.During the investigation it was found that p/n 2055a lot aaac784 (hook blade) was packaged on the same day (feb/01/2017) that p/n 3054 lot aaah041 (triangular blade).The most probable root cause for incorrect device is inadequate line clearance between the run of these two lots.As a capa was already open to follow up line clearance issues and the following corrective actions have been implemented since the manufacture of the affected lot.No risk has been identified since both triangular and hook blades are to be used for the same indication.The triangular blade is a bit more aggressive than the hook because of sharp edges but the surgeon should be able to complete the surgery without any delay or harm for the patient or users.Based on the investigation, the root cause can be assigned to the supplier.
 
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Brand Name
ENDOTRAC ECTR STERILE HOOK BLADE
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key6969912
MDR Text Key90793562
Report Number0008031020-2017-00621
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K922391
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 02/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2022
Device Catalogue Number2055
Device Lot NumberAAAC784
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/06/2017
Initial Date FDA Received10/23/2017
Supplement Dates Manufacturer Received10/26/2017
01/22/2018
Supplement Dates FDA Received10/26/2017
02/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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