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

Catalog Number 704002

Device Problem Disconnection (1171)

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

Event Date 03/16/2014

Event Type  malfunction  

Event Description

It was reported that lag screw was inserted in the femoral head after traditional measuring techniques.Lag screw wrench and internal connection rod disconnected from the lag screw.Residents were asked to reinsert the teeth of the wrench under floro then rethread the internal connection rod.They felt that they had done so, but could not advance or remove lag screw and felt that the teeth and internal threads in the lag screw had stripped and we needed to explore other options to advance the screw to desired its desired position.

Manufacturer Narrative

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

Manufacturer Narrative

The reported incident that one-step insertion wrench omega was alleged of issue s-43 (assembling issue) could be confirmed (component / devise stuck ).Based on investigation, the root cause was attributed to a design related issue.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time for this article as such.The problem had been addressed and a corrective action has been already implemented (ecr/ecn sel (b)(4)) in order to enhance the elastosil t-handle (large ao coupling) (b)(4) and prevent such problems in the future.The design will be fully rotational again, as it was prior to the implementation of (b)(4) - however the play between components *-1, *-2 und *-3 is increased to avoid jamming - improved dimensioning implies a more functional inspection method of component *-1.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

It was reported that lag screw was inserted in the femoral head after traditional measuring techniques.Lag screw wrench and internal connection rod disconnected from the lag screw.Residents were asked to reinsert the teeth of the wrench under floro then rethread the internal connection rod.They felt that they had done so, but could not advance or remove lag screw and felt that the teeth and internal threads in the lag screw had stripped and we needed to explore other options to advance the screw to desired its desired position.

• Brand Name: ONE-STEP INSERTION WRENCH OMEGA
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3738093
• MDR Text Key: 14880053
• Report Number: 0008031020-2014-00153
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2014

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: R20965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2014
• Initial Date FDA Received: 04/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR