MAUDE Adverse Event Report: STRYKER GMBH STANDARD LAG SCREW OMEGA 110MM LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 33625110

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/05/2017

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 the lag screw sheared at the end and that this might have been user error / overtightened.Another lag screw was inserted with no other issues.There was a minor operative delay.No unintended metal was left in the patient.

Manufacturer Narrative

The reported event that standard lag screw omega 110mm length was alleged of 'device damaged' 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.The threaded part of the lag screw is still intact though.The operative technique (omg-st-2 en omega3 compression hip screw optech) was reviewed: 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 the lag screw sheared at the end and that this might have been user error / overtightened.Another lag screw was inserted with no other issues.There was a minor operative delay.No unintended metal was left in the patient.

• Brand Name: STANDARD LAG SCREW OMEGA 110MM LENGTH
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6764929
• MDR Text Key: 81811708
• Report Number: 0008031020-2017-00467
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K955306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 33625110
• Device Lot Number: V24204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other