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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN 4MM AXSOS STAINLESS LOCKING SCREW; IMPLANT

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STRYKER GMBH UNKNOWN 4MM AXSOS STAINLESS LOCKING SCREW; IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problems Sticking (1597); Device Inoperable (1663)
Patient Problem No Information (3190)
Event Date 05/14/2018
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Customer has discarded product.
 
Event Description
The surgeon was trying to advance the 4mm locking screws into the insert and they were becoming stuck.Eventually the surgeon did not use locking screws and reverted to non locking.It had no adverse effects to the patient and it added 15 minutes to the procedure.The customer was adamant that they used the correct drill and the screws were correctly aligned.
 
Manufacturer Narrative
The reported event that unknown_(b)(4)_product (as reported: 4mm axsos stainless locking screw) was alleged of issue s-36 (component/device stuck) could be confirmed based on the images provided for evaluation.A device inspection was not possible since the affected device was not returned.However, based on the images received, both the screws were found to be stuck with the corresponding locking inserts.However, as the devices were not received for evaluation, a sample locking screw axsos 4.0mm / l48mm was used with the corresponding locking insert (locking insert axsos 4.0mm locking set & locking insert - inserter axsos 4.0mm locking set) and as shown in the image documentation, the inserter was easily able to hold the insert without dropping it.After the insert is put on the plate, according to the optech, the locking screw has to be inserted in it.The screw was able to get inserted in the insert without any problem.The insert reaches the top of the screw without any issue.Furthermore, the screw head was able to be locked in the insert without any problem either.Based on the above facts, the root cause of the reported event is not related to a deficiency of the device, but is rather linked to user related issue.Some of the possible causes are improper preselection/measuring of components, insertion of screws at an inappropriate angle, free hand drilling etc.The batch record could not be reviewed because the affected device was not returned and the lot number was not communicated.If device is returned or any further information is provided, the investigation report will be reassessed.
 
Event Description
The surgeon was trying to advance the 4mm locking screws into the insert and they were becoming stuck.Eventually the surgeon did not use locking screws and reverted to non locking.It had no adverse effects to the patient and it added 15 minutes to the procedure.The customer was adamant that they used the correct drill and the screws were correctly aligned.
 
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Brand Name
UNKNOWN 4MM AXSOS STAINLESS LOCKING SCREW
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key7531673
MDR Text Key109230185
Report Number0008031020-2018-00379
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/12/2018
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 Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/14/2018
Initial Date FDA Received05/22/2018
Supplement Dates Manufacturer Received05/24/2018
Supplement Dates FDA Received06/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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