MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL HUMERUS PLATE VARIAX FOR LEFT HUMERUS 8 HOLE / L156MM; PLATE, FIXATION, BONE

Model Number 629208

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Limb Fracture (4518)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "the patient underwent open reduction and internal fixation of the humerus fracture on (b)(6) 2019.There were no adverse reactions after procedure.Fracture alignment line was good, plate fixation was good, wound healing was good after hospital discharge.On (b)(6) 2020, the patient fell down again without complete healing of the fracture.The internal plate breaks and the fracture ends break again.The re-operation was performed with plate fixation.".

Event Description

As reported: "the patient underwent open reduction and internal fixation of the humerus fracture on (b)(6), 2019.There were no adverse reactions after procedure.Fracture alignment line was good, plate fixation was good, wound healing was good after hospital discharge.On (b)(6), 2020, the patient fell down again without complete healing of the fracture.The internal plate breaks and the fracture ends break again.The re-operation was performed with plate fixation.".

Manufacturer Narrative

Correction: refer to d4 lot number, d9/h3 the reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The event description clearly states that the patient fell prior to the breakage of the plate.Based on this, the root cause was attributed to be patient related.The event was caused by the fall of the patient.Indeed, it is clearly mentioned in the ifu that the implants are not supposed to withstand forces due to a fall.A review of the device history was not possible because the lot number that was communicated is not valid, since it corresponds to a fixos screw (another catalog# ) in our database and not the humeral plate reported.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.H3 other text : device disposition is unknown.

• Brand Name: DISTAL LATERAL HUMERUS PLATE VARIAX FOR LEFT HUMERUS 8 HOLE / L156MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10795868
• MDR Text Key: 216417124
• Report Number: 0008031020-2020-02425
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613154970520
• UDI-Public: 07613154970520
• Combination Product (y/n): N
• PMA/PMN Number: K101056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 629208
• Device Catalogue Number: 629208
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR