MAUDE Adverse Event Report: DISTAL POSTERIOR LATERAL HUMERUS PLATE VARIAX FOR LEFT HUMERUS 10 HOLE / L173; PLATE, FIXATION, BONE

Model Number 629250S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

The device will now be returned.If additional information becomes available, it will be provided in a supplemental report.

Event 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.

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 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 POSTERIOR LATERAL HUMERUS PLATE VARIAX FOR LEFT HUMERUS 10 HOLE / L173
• Type of Device: PLATE, FIXATION, BONE
• MDR Report Key: 12391203
• MDR Text Key: 268895021
• Report Number: 0008031020-2021-00389
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540597731
• UDI-Public: 04546540597731
• 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: 10/26/2021

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 Model Number: 629250S
• Device Catalogue Number: 629250S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• 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): Other