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

Catalog Number	56-01210
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7732918
• Report Number: 0008031020-2018-00530
• Device Sequence Number: 2771193
• Product Code: HRS
• UDI-Device Identifier: 04546540652461
• UDI-Public: 04546540652461
• Combination Product (Y/N): N
• PMA/510(K) Number: K112455
• 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): 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 56-01210
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other