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

Model Number	3362-5-095
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the omega 3 system was chosen to provide fixation of an intertrochanteric fracture on a male trauma patient of unknown age.The omega 135° guide was used to insert the omega guide pin.Omega reamer and omega tap were used before insertion of lag screw.An omega 3 lag screw (95mm) was implanted over the omega guide pin.The surgeon decided to exchange it for a longer lag screw.The rear part (screw/ driver interface) of the 95mm lag screw was visually deformed after extraction.An omega 3 lag screw (105mm) was then inserted over the guide wire.During insertion, the distal (rear) part of the screw began to deform (at the screw/ driver interface).The deformation was visualized by the surgeon.The surgeon attempted to install the omega 3 stabilization plate onto the lag screw without success.The lag screw screwdriver was not able to remove the damaged lag screw.A conical extractor was used to successfully remove the lag screw.A new omega 3 lag screw (100mm) was then inserted over the guide wire.The omega stabilization plate did not fit the bone to the surgeon's liking and was replaced with an omega short barrel hip plate 135°, 2 hole.X (4.5 x 40mm) screws were inserted through the plate into the femur shaft to secure the plate to the bone." additionally reported: "surgery was prolonged about an hour and a half because of the implant malfunction.".
Event or Problem Description
As reported: "the omega 3 system was chosen to provide fixation of an intertrochanteric fracture on a male trauma patient of unknown age.The omega 135° guide was used to insert the omega guide pin.Omega reamer and omega tap were used before insertion of lag screw.An omega 3 lag screw (95mm) was implanted over the omega guide pin.The surgeon decided to exchange it for a longer lag screw.The rear part (screw/ driver interface) of the 95mm lag screw was visually deformed after extraction.An omega 3 lag screw (105mm) was then inserted over the guide wire.During insertion, the distal (rear) part of the screw began to deform (at the screw/ driver interface).The deformation was visualized by the surgeon.The surgeon attempted to install the omega 3 stabilization plate onto the lag screw without success.The lag screw screwdriver was not able to remove the damaged lag screw.A conical extractor was used to successfully remove the lag screw.A new omega 3 lag screw (100mm) was then inserted over the guide wire.The omega stabilization plate did not fit the bone to the surgeon's liking and was replaced with an omega short barrel hip plate 135°, 2 hole.X (4.5 x 40mm) screws were inserted through the plate into the femur shaft to secure the plate to the bone.".Additionally reported: "surgery was prolonged about an hour and a half because of the implant malfunction.".
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by inadequate use (implant selection).The device inspection revealed the following: the returned lag screw is severely damage / deformed (both connection pins are splayed open).This clearly indicates that either the lag screw had not been properly assembled with the lag screw adapter (got loose) or just inadequate use has resulted in these deformations.Additionally: 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.Based on investigation, the root cause was attributed to be user related.The failure was caused by inadequate use (implant selection).If any further information is provided, the investigation report will be updated.

• Brand Name: STANDARD LAG SCREW OMEGA 95MM LENGTH
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9614121
• Report Number: 0008031020-2020-00114
• Device Sequence Number: 13560168
• Product Code: KTT
• UDI-Device Identifier: 07613327093032
• UDI-Public: 07613327093032
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K955306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: 3362-5-095
• Device Catalogue Number: 33625095
• Device Lot Number: B95318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1