MAUDE Adverse Event Report: STRYKER GMBH STANDARD LAG SCREW OMEGA 120MM LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 33625120

Device Problems Bent (1059); Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that when the surgeon was inserting a dhs lag screw, it sheared at the end and bent.There was a surgical delay of 5 minutes.

Manufacturer Narrative

The reported event that standard lag screw omega 120mm length was alleged of 'device deformed' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by possible overtightening (as indicated).The device inspection revealed the following: both positioning grooves of the end part of the lag screw are clearly badly damaged (deformed and spread out).It indicates that either the lag screw had not been properly assembled with the lag screw adapter or just inadequate use (overtightening) has resulted in these deformations.Even some traces of force are visible on the shaft, which indicate that the user encountered some difficulties during insertion.The threaded part of the lag screw is still intact though.Note: the lag screw should be centered in the head on both anterior-posterior and lateral views, within 10 millimeters of subchondral bone.Application of the template to an x-ray of the uninvolved hip may help simulate reduction of the fractured hip.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.

Event Description

The customer reported that when the surgeon was inserting a dhs lag screw it sheared at the end and bent.There was a surgical delay of 5 minutes.

• Brand Name: STANDARD LAG SCREW OMEGA 120MM 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: 7294287
• MDR Text Key: 101123143
• Report Number: 0008031020-2018-00139
• 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: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 33625120
• Device Lot Number: L20515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Date Manufacturer Received: 04/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other