MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL MEDIAL TIBIA PLATE, L PANGEA TIBIA PLATING SYSTEM 3.5MM, 86MM/5 HOLES; PLATE, FIXATION, BONE

Catalog Number	540405
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "locking screw was placed using a variable angle drill guide and torque limiter in a pangea proximal medial tibia plate.The locking screw didn¿t lock and went through the plate.Surgeon had to leave screw in the bone because couldn¿t get it out from under the plate.Two additional screws were also unable to be locked but didn¿t go through the plate.Sales rep believes surgeon was able to drill outside of the cone and that¿s why the screw didn¿t lock.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required currently.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.In relation to the locking function the following statement of the pangea tibia plating system operative technique can be pointed out: pangea¿s variable angle locking technology uses a cocr locking screw, which is harder than the ti6ai4v eli plate, allowing for the screwhead¿s threads to form a definitive locking position in the plate¿s locking hole by engaging the softer ti6ai4v eli material.This technology allows the user to aim and lock the screw int the plate within a true 30-degree cone of the predetermined hole trajectory.The variable angle drill guide provided with the system offers guidance with respect to the limit of the 30-degree cone.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "locking screw was placed using a variable angle drill guide and torque limiter in a pangea proximal medial tibia plate.The locking screw didn¿t lock and went through the plate.Surgeon had to leave screw in the bone because couldn¿t get it out from under the plate.Two additional screws were also unable to be locked but didn¿t go through the plate.Sales rep believes surgeon was able to drill outside of the cone and that¿s why the screw didn¿t lock.".

• Brand Name: PROXIMAL MEDIAL TIBIA PLATE, L PANGEA TIBIA PLATING SYSTEM 3.5MM, 86MM/5 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19448800
• Report Number: 0008031020-2024-00237
• Device Sequence Number: 11566503
• Product Code: HRS
• UDI-Device Identifier: 07613327611410
• UDI-Public: 07613327611410
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K231262
• 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): 07/23/2024

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: 540405
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown