MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3 10.5X100MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3066-0100S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Perforation (2001); Implant Pain (4561)
Date of Event	07/30/2020
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
As reported: "in a regular inspection, it was confirmed that the u lag screw of gamma3 was penetrating.We don't know the cause.It seems that there was one fall.The patient's symptom is mild pain.".
Event or Problem Description
As reported:"in a regular inspection, it was confirmed that the u lag screw of gamma3 was penetrating.We don't know the cause.It seems that there was one fall.The patient's symptom is mild pain.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the x-rays were available to confirm the alleged failure mode.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 investigation, possible cause of failure could be user related issue (insufficient tightening of set screw to fix the position of lag screw) if any further information is provided, the complaint report will be updated.

• Brand Name: U-BLADE SET, TI GAMMA3 10.5X100MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10451818
• Report Number: 0009610622-2020-00487
• Device Sequence Number: 3395630
• Product Code: HSB
• UDI-Device Identifier: 04546540596000
• UDI-Public: 04546540596000
• Combination Product (Y/N): N
• PMA/510(K) Number: K043431
• 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): 10/28/2020

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: 11/30/2024
• Device Model Number: 3066-0100S
• Device Catalogue Number: 30660100S
• Device Lot Number: KO7FE8E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 10/28/2020
• 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: Other