MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH ONE-STEP INSERTION WRENCH OMEGA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 704002

Device Problems Disconnection (1171); Device Slipped (1584); Material Deformation (2976)

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

Event Date 08/18/2014

Event Type  malfunction  

Event Description

It was reported that during primary left hip surgery, while tightening handle, it jumped and screw lost connection.The back end of the lag screw slipped from engagement.The prongs of lag screw and the prongs on the shaft lost connection.This deformed the back end of the lag screw.While the lag screw was in the patient they had to bur down the back end of the lag screw.This lead to a delay in surgery of a couple minutes.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: the reported event of the assembling issue for one-step insertion wrench omega could be confirmed.Based on the investigation, the root cause was attributed to a user related issue.First failure mode hypothesis: 704004 connecting bolt and 3362-5-050_-130 lag screw were crosst readed.When the torque was applied both bending moment and axial forces broke the thread and the connection.Second failure mode hypothesis: there was resultant play between 704002 one-step insertion wrench and 3362-5-050_-130 lag screw.Therefore the 704004 connecting bolt was not fully threaded in the lag screw.The result is similar to the first hypothesis.Third failure mode hypothesis: 704003 one-step insertion sleeve was used incorrectly not preventing bending moment on 704004 connecting bolt, 704002 one-step insertion wrench and 3362-5-050_-130 lag screw.The result is similar to the first hypothesis.Fourth failure mode hypothesis: hard cortical bone increased the torque required to insert the 3362-5- 050_-130 lag screw.In this case it is advised to tap the femoral head / neck.In such case 704007 lag screw tap and 704008 lag screw tap sleeve are available.To be able to assess the situation fully, investigation of 3362-5-050_-130 lag screw is required.According to the event description the lag screw was implanted.Moreover additional information such as surgical.Technique and all the references used in or would be required to confirm the exact failure mode.Notes: "femoral head / neck tapping the lag screw,tap should be used when good quality, dense bone is encountered one-step insertion assembly: assemble the one-step insertion sleeve to the one-step insertion wrench between the hip plate and the lag screw" (982271 2003 omega2 optech) "always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.Before every operation, ensure that all devices to be used during the operation function correctly with each other.In the course of the operation, repeatedly check that the connections required for precise positioning between the implant and instruments, or between the instruments themselves, are secure."(v15011 rev k 01-2014 instruments ifu) additional usage factor of 9 has been used for one-step insertion wrench omega covering year 2010 to 2015 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 the 3362-5-050_-130 lag screw is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that during primary left hip surgery, while tightening handle, it jumped and screw lost connection.The back end of the lag screw slipped from engagement.The prongs of lag screw and the prongs on the shaft lost connection.This deformed the back end of the lag screw.While the lag screw was in the patient they had to bur down the back end of the lag screw.This lead to a delay in surgery of a couple minutes.

• Brand Name: ONE-STEP INSERTION WRENCH OMEGA
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4087840
• MDR Text Key: 4745039
• Report Number: 0008031020-2014-00432
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2014

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: 704002
• Device Lot Number: R13808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2014
• Initial Date FDA Received: 09/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2013
• 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