MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X320MM X 120°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3420-0320S

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Date 08/12/2022

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.

Event Description

It was reported that primary surgery for a trochanteric fracture was performed on (b)(6) 2021.On an unknown date, one distal screw was removed due to postoperative pseudarthrosis and dynamization was attempted, but there was no bony fusion and the nail and distal screw broke off.Revision surgery to tha was performed on (b)(6) 2022.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence 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.No indications of material, manufacturing or design related problems were found during the investigation.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.If any further information is provided, the investigation report will be reassessed.

Event Description

It was reported that primary surgery for a trochanteric fracture was performed on (b)(6) 2021.On an unknown date, one distal screw was removed due to postoperative pseudarthrosis and dynamization was attempted, but there was no bony fusion and the nail and distal screw broke off.Revision surgery to tha was performed on (b)(6) 2022.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X320MM X 120°
• Type of Device: 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: 15439808
• MDR Text Key: 300067329
• Report Number: 0009610622-2022-00429
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375209
• UDI-Public: 04546540375209
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3420-0320S
• Device Catalogue Number: 34200320S
• Device Lot Number: K0CC71B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female