MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X105MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30600105S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
Event or Problem Description
It was reported that patient's right femur was revised.As reported by the rep "lag screw cut out".A gamma3 nail, lag screw, and locking screw were revised to a restoration modular stem construct with an lfit v40 head and uhr bipolar component.Rep reported that no further information is available due to hospital policy.
Event or Problem Description
It was reported that patient's right femur was revised.As reported by the rep "lag screw cut out".A gamma3 nail, lag screw, and locking screw were revised to a restoration modular stem construct with an lfit v40 head and uhr bipolar component.Rep reported that no further information is available due to hospital policy.
Additional Manufacturer Narrative
The reported event that lag screw, ti gamma3® ø10.5x105mm was alleged of issue (implant revision / removal without implant breakage) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on the complaint history and the risk management file, possible cause for such failure is handling failure (e.G.Implant was damaged when implanted; inadequate reposition, wrong nail geometry chosen, position of implant is incorrect, mislocking, misdrilling).Revision surgery due to cut out is a typical complication of proximal femoral nailing.This harm does not primly depend on the implant.It is mostly caused by the kind of fracture, patient's general condition (osteoporosis), and primly the respective surgical technique (correct positioning of the lag screw in the center of the femoral head).If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: LAG SCREW, TI GAMMA3® Ø10.5X105MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8171150
• Report Number: 0009610622-2018-01512
• Device Sequence Number: 11423192
• Product Code: HSB
• UDI-Device Identifier: 04546540374950
• UDI-Public: 04546540374950
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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: 12/31/2021
• Device Catalogue Number: 30600105S
• Device Lot Number: K0A8EC0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 02/05/2019
• 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: 70 YR
• Patient Weight: 71