MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3125-1180S

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 12/02/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded by the hospital.

Event Description

It was reported that gamma3 nail was broken at the lag screw junction.Patient was experiencing pain, implant was removed and replaced with a depuy synthes tfna with traumacem.

Manufacturer Narrative

The reported event could be confirmed, since an x-ray was provided showing the broken nail.The device was not returned and therefore a product inspection could not be performed.Since one x-ray was provided, the opinion of a medical expert was requested.Their statement is as follows when asked if it was possible to determine any factor that could have contributed to the breakage: " it is clear, that a non-union occurred, here.One reason might be the fracture pattern with a major fragment dislocation of the lesser trochanter-this leads to a medial instability and may have contributed to the failure.A surgical measurement would have been the restoration of the anatomy with an additional cerclage to reduce the gap and provide more stability.Additionally, the patient's advanced age and low bmi may favor a metabolic cause for the observed difficulties.The medical expert also stated "that since only one x-ray was available an assessment is only possible to a very limited extent and misinterpretations can occur much more easily'.More information is required for a full analysis.Based on the information available, the root cause can at least partially be attributed to a patient related issue.The failure was caused by the fracture pattern, as well as the patient's conditions related to their age and bmi.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that gamma3 nail was broken at the lag screw junction.Patient was experiencing pain, implant was removed and replaced with a depuy synthes tfna with traumacem.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13102038
• MDR Text Key: 284645905
• Report Number: 0009610622-2021-00828
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375070
• UDI-Public: 04546540375070
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/03/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 3125-1180S
• Device Catalogue Number: 31251180S
• Device Lot Number: K0CC037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 96 YR
• Patient Sex: Female
• Patient Weight: 49 KG