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

Model Number	56-01210
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "when using variax dr with aiming block, the surgeon experienced that the narrow block could not fit/stick to the plate.The aiming blocks does manage to sit tight but only the narrow are not able to.Also one of the fixation pins are broken." the procedure was delayed by a few minutes, they chose to use the drill guide instead.No debris was left in patient¿s body.
Event or Problem Description
As reported: "when using variax dr with aiming block, the surgeon experienced that the narrow block could not fit/stick to the plate.The aiming blocks does manage to sit tight but only the narrow are not able to.Also one of the fixation pins are broken." additional information received: the procedure was delayed by a few minutes,- they chose to use the drill guide instead.No debris was left in patient¿s body.
Additional Manufacturer Narrative
The reported event could be confirmed, since the guide pin is not in position anymore.The device inspection revealed the following: the visual inspection has shown that the guide pin of the fixation pin is missing as the welding seam is broken, the pin was not returned for evaluation.The microscopic evaluation has shown that the welding seam was carried out cleanly and evenly around the pin, there is no indication of any manufacturing related issue.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.Nevertheless it can be mentioned that the design of this in the year 2012 manufactured device has been improved in the meantime to avoid such an occurrence in the future.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a mechanical overload during the use of the device, this overload did lead to a breakage of the welding seam of the pin.In this relation following statement of the operative technique can be pointed out: "[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).Once the block is mounted to the plate, verify the alignment by passing a k-wire through the k-wire holes.This should be done prior to mounting the plate to the bone.] if more information is provided, the case will be reassessed.

• Brand Name: VARIAX DR AIMING BLOCK FIXATION PIN
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12818712
• Report Number: 0008031020-2021-00466
• Device Sequence Number: 5615216
• Product Code: HRS
• UDI-Device Identifier: 04546540652461
• UDI-Public: 04546540652461
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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 Model Number: 56-01210
• Device Catalogue Number: 56-01210
• Device Lot Number: AC09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown