MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X340MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-1340S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that a gamma 3 shs migrated three months after surgery, resulting in a revision.
Event or Problem Description
It was reported that a gamma 3 shs migrated three months after surgery, resulting in a revision.
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was not returned for evaluation.The reported event could be confirmed, since reported revision as a result of a migrated lag screw.The available image was forwarded to a health care professional, which confirmed the migration as well but cannot be further specified based on existing one plane view.No further additions.The basics of the gamma-system are the interaction of nail set including a set screw and lag screw in the proximal area.The intention is to allow the fracture site to subside [if the fracture gap is too big] in order to support bone union.This requires motion in a relative rigid construction and is solved by lateralization of the lag screw.The set screw ¿ as part of the nail kit - is designed to fit into one of the four grooves of the shaft of the lag screw with ascending shapes at both medial and lateral.This prevents both rotation and complete migration of the lag screw but allows sliding in a limited and defined range.Known from previous cases it¿s rather related to a not properly seated set screw [set screw had not been reached the ground of the groove resp.Was unscrewed for more than ¼ of a turn resulting in exceeded motion of the lag screw towards medial].More detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.Therefore, from technical point of view in this case a statement is impossible.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.With available information a deficiency of the devices in question was not verified.H3 other text : device disposition unknown.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X340MM X 125°
• 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16000409
• Report Number: 0009610622-2022-00586
• Device Sequence Number: 12167429
• Product Code: HSB
• UDI-Device Identifier: 07613252273820
• UDI-Public: 07613252273820
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• 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): 03/29/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 3425-1340S
• Device Catalogue Number: 34251340S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2022
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown