MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA 3 NAIL; IMPLANT

Catalog Number UNK_KIE

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Implant Pain (4561)

Event Date 07/21/2021

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

Please see user report to (b)(6) translated below: fracture of the gamma 3 nail (statically locked).The osteosynthesis material broke in the passage of the sh screw (femoral neck thus variably dislocated).The gamma 3 nail was disposed of after consultation with the patient.On (b)(6) 2021: pertrochanteric femur fracture with osteosynthetic treatment (gamma 3 nail).On (b)(6) 2021 fall and patient admission in the clinic (cct - exclusion of trauma sequelae).On (b)(6) 2021: admission in the clinic (without trauma) - acute pain symptoms and referral to endogap on (b)(6) 2021.On (b)(6) 2021 removal of the broken gamma 3 nail (statically locked) and supply with a cementless htep (cerclage femur).

Event Description

Please see user report to bfarm translated below: fracture of the gamma 3 nail (statically locked).The osteosynthesis material broke in the passage of the sh screw (femoral neck thus variably dislocated).The gamma 3 nail was disposed of after consultation with the patient.(b)(6) 2021: pertrochanteric femur fracture with osteosynthetic treatment (gamma 3 nail).(b)(6) 2021: fall and patient admission in the clinic (cct - exclusion of trauma sequelae).(b)(6) 2021: admission in the clinic (without trauma) - acute pain symptoms and referral to endogap on (b)(6) 2021.(b)(6) 2021: removal of the broken gamma 3 nail (statically locked) and supply with a cementless htep (cerclage femur).

Manufacturer Narrative

Correction: please refer to h6 results code.The reported event could be confirmed, although the device was not returned but a couple of x-ray were shared which confirms the reported failure mode.A device inspection was not possible since the affected device was not returned, and no other evidence were provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.A formal medical opinion was sought from an independent medical professional based on the x-rays provided, but with the limited amount of information it was not possible to determine the exact cause.He opined that looking at the provided x-rays, signs of a starting/ongoing hypertrophic non-union could be observed.These fractures are known for their instability and most often of a lack of compression at the fracture site, after fixation, which causes movement at the fracture site.This movement will prevent the bone from healing and cause movement in the interface between the nail and the screw continuously.The movement results in friction/ fatigue/ breakage etc.Looking at the event, it seems that the fracture did not heal after the initial surgery.The attached x-rays show non-union.The gamma-nail is not intended to weight bear for such a long time, which is stated in our labelling documents.More information, patient details as well as the affected device must be available in order to determine the exact root cause of the issue.However, most probably the breakage occurred due to overloading of the nail as a result of non-union.The non-union is most probably due to the complex nature of the fracture and due to an inadequate reduction of the fracture.If the device is returned or any additional information is provided, the investigation will be reassessed.

• Brand Name: UNKNOWN GAMMA 3 NAIL
• Type of Device: IMPLANT
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12392233
• MDR Text Key: 268975641
• Report Number: 0009610622-2021-00674
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female
• Patient Weight: 46 KG