MAUDE Adverse Event Report: STRYKER GMBH VARIAX DR AIMING BLOCK FIXATION PIN; PLATE, FIXATION, BONE

Catalog Number 56-01210

Device Problems Improper or Incorrect Procedure or Method (2017); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

The aiming block did not attach to the plate during the operation of (b)(6) not use the block guide and use to the polyaccial guide.Confirmed the postoperative instruments, found out that there was no tip of the aiming block's fixation pins out of the three.It is unknown where i lost it.

Event Description

The aiming block did not attach to the plate during the operation of variax dr.Not use the block guide and use to the polyaccial guide.Confirmed the postoperative instruments, found out that there was no tip of the aiming block's fixation pins out of the three.It is unknown where i lost it.

Manufacturer Narrative

The reported event that variax dr aiming block fixation pin was alleged of 'not functional' 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 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.Device was not returned.

• Brand Name: VARIAX DR AIMING BLOCK FIXATION PIN
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7732918
• MDR Text Key: 115650371
• Report Number: 0008031020-2018-00530
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540652461
• UDI-Public: 04546540652461
• Combination Product (y/n): N
• PMA/PMN Number: K112455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 56-01210
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other