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

Model Number	56-01210
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
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: "one fixation pin felt stuck while trying to remove it from the plate.When it came out, it was broken.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.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.However, based on past complaints history the most probable root cause could be, but not limited to: overtightening of the pin.The instructions for use clearly cautions the user: ¿caution: fixation pin should not be over-tightened by joystick (finger tighten only).Over-tightening will compromise the integrity of the fixation pin, resulting in possible breakage or deformation of the fixation pin, and lead to aiming block assembly/disassembly failures.¿ if the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "one fixation pin felt stuck while trying to remove it from the plate.When it came out, it was broken.".

• 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
• MDR Report Key: 11231269
• Report Number: 0008031020-2021-00031
• Device Sequence Number: 16984294
• Product Code: HRS
• UDI-Device Identifier: 04546540652461
• UDI-Public: 04546540652461
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K112455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1