MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X100MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30600100S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Irritation (1941); Injury (2348)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device disposition is unknown.
Event or Problem Description
It was reported the patient's right femur was revised because the lag screw of the gamma nail was sitting proud and causing hip irritation for the patient.The lag screw was removed.None of the other devices in the gamma nail construct were removed.Rep confirmed no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported the patient's right femur was revised because the lag screw of the gamma nail was sitting proud and causing hip irritation for the patient.The lag screw was removed.None of the other devices in the gamma nail construct were removed.Rep confirmed no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
The reported could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.More detailed information about the complaint event such as operative reports, x-rays, patient details, as well as the affected device must be available in order to determine the root cause of the complaint event.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 material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instruction for use was reviewed: 6adverse effects: conditions attributable to non-union, osteoporosis, osteomalicia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.Improper alignment can cause a mal-union of the bone and/or bending, cracking or even breakage of the device.¿ if the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LAG SCREW, TI GAMMA3® Ø10.5X100MM
• 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: 9163952
• Report Number: 0009610622-2019-00856
• Device Sequence Number: 409029
• Product Code: HSB
• UDI-Device Identifier: 04546540374943
• UDI-Public: 04546540374943
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: 11/30/2022
• Device Catalogue Number: 30600100S
• Device Lot Number: K0B03B4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 12/17/2019
• 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: 82 YR