MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X110MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3060-0110S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
It was reported, the g3 femoral neck screw has migrated through the nail into the patient's pelvis after gamma 3 surgery.According to the surgeon, they exactly used the operation description and also the locking bolt was correctly locked in the grooves of the screw.Patient had to be operated again, got a femur replacement.
Additional Manufacturer Narrative
Correction: d4 (lot #).A review of the device history for this lot did not indicate any abnormalities.
Event or Problem Description
It was reported, the g3 femoral neck screw has migrated through the nail into the patient's pelvis after gamma 3 surgery.According to the surgeon, they exactly used the operation description and also the locking bolt was correctly locked in the grooves of the screw.Patient had to be operated again, got a femur replacement.
Additional Manufacturer Narrative
The reported event could be confirmed, although the device was not returned for evaluation, a few x-rays were provided which confirms the alleged failure (migration of lag-screw).Through one of the given x-rays, it is visibly evident that the set screw was not properly engaged into the groove of the lag screw.In the x-ray, the tip of the set screw could be easily spotted, with quite some distance above the lag screw.This is the primary reason why the lag screw migrated into the pelvis in over a months¿ time, as a result of it being not secured with the set screw at all.The x-rays and the surgery report were provided to the medical expert, through which he opined and presented his doubts regarding proper fixation of the lag screw: ¿in the given case, there was almost no hope to expect a healing of the subtrochanteric fracture with a nail and it is doubtful, whether the lag screw was locked correctly.¿ a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation the root cause of the complaint is user related.The migration of the lag screw happened due to inadequate insertion of the set screw inside the nail, leading to inadequate fixation of the lag screw with the set screw and setting it free.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported, the g3 femoral neck screw has migrated through the nail into the patient's pelvis after gamma 3 surgery.According to the surgeon, they exactly used the operation description and also the locking bolt was correctly locked in the grooves of the screw.Patient had to be operated again, got a femur replacement.

• Brand Name: LAG SCREW, TI GAMMA3® Ø10.5X110MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9520091
• Report Number: 0009610622-2019-00987
• Device Sequence Number: 546675
• Product Code: HSB
• UDI-Device Identifier: 04546540374967
• UDI-Public: 04546540374967
• Combination Product (Y/N): N
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Model Number: 3060-0110S
• Device Catalogue Number: 30600110S
• Device Lot Number: K08B0E6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 02/27/2020; 04/13/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/14/2020; 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR