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	11/06/2018
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
It was reported that the surgeon could not attached the aiming block to the variaxdr small plate, and forcibly attached.The surgeon could not get out of the block easily after the screws were deployed, and when he pulled it forcibly, he broke the fixation pin and the tip of the pin was left in the patient body.After that, the broken piece was removed with a forceps.
Event or Problem Description
It was reported that the surgeon could not attached the aiming block to the variaxdr small plate, and forcibly attached.The surgeon could not get out of the block easily after the screws were deployed, and when he pulled it forcibly, he broke the fixation pin and the tip of the pin was left in the patient body.After that, the broken piece was removed with a forceps.
Additional Manufacturer Narrative
The reported event that variax dr aiming block fixation pin was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by inadequate applied force.The device inspection revealed the following: the weld of the pin is indeed completely broken apart.As reported the surgeon encountered some difficulties and could not attache the aiming block to the variaxdr small plate without using force.Again there were some problems after the screws were deployed and the fixation pin was forcibly taken out to such an extent that the weld of the lid broke off during this removal attempt.Therefore we can clearly determine that the cause of the pin breakage was due to inadequate applied force during pin removal.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.

• 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: 8139808
• Report Number: 0008031020-2018-01033
• Device Sequence Number: 1406710
• 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): 01/15/2019

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: AH10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/15/2019
• 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