MAUDE Adverse Event Report: STRYKER GMBH STANDARD LAG SCREW OMEGA 95MM LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 33625095

Device Problem Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 12/10/2017

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that in trying to implant an omega hip lag screw, the head of the screw deformed (splayed out), and wouldn't let the side plate slide over the screw.Pliers were used to extract the screw, causing a surgical delay of greater than 1 hour.Another screw was successfully used.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

Event Description

It was reported that in trying to implant an omega hip lag screw, the head of the screw deformed (splayed out), and wouldn't let the side plate slide over the screw.Pliers were used to extract the screw, causing a surgical delay of greater than 1 hour.Another screw was successfully used.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

Manufacturer Narrative

The reported event that standard lag screw omega 95mm length was alleged 'device deformed' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by either inadequate assembly with the lag screw adapter or just inadequate use.The device inspection revealed the following: both returned devices were badly damaged and could therefore not be used anymore.The severe damages / deformations of the front part of the lag screw indicates that either the lag screw had not been properly assembled with the lag screw adapter or just inadequate use has resulted in these damages.The damages / deformations of the inner barrel of the hip plate also clearly indicates, as that the lag screw could not slide into position, that the problem surely occurred during inadequate screw insertion (as mentioned above).The threaded part of the lag screw is still intact though.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

• Brand Name: STANDARD LAG SCREW OMEGA 95MM LENGTH
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7165643
• MDR Text Key: 96617597
• Report Number: 0008031020-2018-00024
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• PMA/PMN Number: K955306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 33625095
• Device Lot Number: L13770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Date Manufacturer Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other