MAUDE Adverse Event Report: DISTAL LATERAL HUMERUS PLATE VARIAX FOR LEFT HUMERUS 10 HOLE / L179MM; PLATE, FIXATION, BONE

Model Number	629210S
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
The customer presented a case where a long distal posterior lateral or distal lateral humeral variax elbow plate was used.They faced a complication which led to stop using the plates for complex distal humeral fractures.X-rays were shown where it looked like there was a loss of reduction after some time.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event, like x-rays, operation reports and as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.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 or Problem Description
The customer presented a case where a long distal posterior lateral or distal lateral humeral variax elbow plate was used.They faced a complication which led to stop using the plates for complex distal humeral fractures.X-rays were shown where it looked like there was a loss of reduction after some time.

• Brand Name: DISTAL LATERAL HUMERUS PLATE VARIAX FOR LEFT HUMERUS 10 HOLE / L179MM
• Common Device Name: PLATE, FIXATION, BONE
• MDR Report Key: 12398341
• Report Number: 0008031020-2021-00395
• Device Sequence Number: 17059207
• Product Code: HRS
• UDI-Device Identifier: 04546540597632
• UDI-Public: 04546540597632
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101056
• 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): 10/25/2021

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: 629210S
• Device Catalogue Number: 629210S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 10/25/2021
• 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: Other