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

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.

• 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 Key: 7531673
• MDR Text Key: 109230185
• Report Number: 0008031020-2018-00379
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 05/24/2018
• Supplement Dates FDA Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other