MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG 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	09/28/2017
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
I could not disconnect the aiming block from the pin because part of the pin is gone.Could not find the broken piece of the pin.It may be in the patient.
Additional Manufacturer Narrative
The reported event that the ¿variax dr aiming block fixation pin¿ could not be disconnected from the aiming block and part of the pin broke, could be confirmed, since the device was returned for evaluation and it matches the reported failure mode.The visual inspection revealed that the screw was received for inspection intact, but with a slightly scratched surface.The fixation spreader has also a scratched surface while the limit pin, is broken/missing.It was reported that during the procedure, the customer could not disconnect well the aiming block from the design pin, and managed to remove it with the use of another device (ereba).As per op.Tech.(variax distal radius op-tech): ¿removal of aiming block: attach the joystick to the fixation pin by tightening the black grasping sleeve (clockwise).Turn the joystick knob counterclockwise to open fixation the pin (approx.2 turns).Remove the joystick/fixation pin assembly from the aiming block.Remove aiming block from the plate.If necessary, a screw can be placed in hole used for fixation of the aiming block.Ensure that all screw heads are fully seated onto the plate and fully tightened.Attention: fixation pin should not be overly tightened as this may damage the threads on the pin.Only moderate effort is needed (finger tighten only).¿ an improper usage of the aiming block, could have compromised the integrity of the device, which is definitely a deviation from the specifications.As per ifu (v15011): ''ensure that you are familiar with the recommended uses, compatibility and correct handling of the instrument! only use an instrument for its intended purpose.Improper use of instruments might lead to loss in function or usage.Always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.The design of the instrument must not be modified in any way." based on investigation, the root cause was attributed to a user related issue.Most likely during usage, the device experienced high mechanical forces, and broke.A review of the device history for the reported lot did not indicate any abnormalities.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 any further information is provided, the investigation report will be updated.In terms of good will, a credit note will be provided.
Event or Problem Description
I could not disconnect the aiming block from the pin because part of the pin is gone.Could not find the broken piece of the pin.It may be in the patient.

• Brand Name: VARIAX DR AIMING BLOCK FIXATION PIN
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 6973045
• Report Number: 0008010177-2017-00268
• Device Sequence Number: 519008
• 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): 11/30/2017

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: AE05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/30/2017
• 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