MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 3 4.0MM / L70MM; PLATE, FIXATION, BONE

Model Number	661070
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
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.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that there were 3 screws that did not allow locking on the plate used, even following the surgical technique correctly.They did not lock with the dynamometric screwdriver, the screws continued to roll remaining under the plate the others screws that were placed worked and got blocked.Surgeon decided to remove them since they are not fulfilling any function.There was an unspecified surgical delay resulting from this event.
Event or Problem Description
It was reported that there were 3 screws that did not allow locking on the plate used, even following the surgical technique correctly.They did not lock with the dynamometric screwdriver, the screws continued to roll remaining under the plate the others screws that were placed worked and got blocked.Surgeon decided to remove them since they are not fulfilling any function.There was an unspecified surgical delay resulting from this event.
Additional Manufacturer Narrative
The reported event could not be confirmed.The device inspection revealed the following: the identification of the three locking screws of were confirmed based on the catalog # and lot # marked.All three screws show signs of wear on the threaded head and body, which occurred most probably during the failed insertion.In addition to wear, the screw catalog # 661075; lot # k37727 shows damages on the threaded head.A fully functional axsos proximal lateral tibia, with which the three screws are compatible, was selected for the functional inspection.All three locking screws were successfully inserted and tightened into the locking holes.The reported event, that the screws continued to roll under the plate after the insertion, was not observed.Despite the described wear and damage, all three locking screws were fully functional.Thus, the complaints could not be confirmed.Based on investigation, the root cause was attributed to an user related issue.The surgeon most probably failed to follow the operative technique and tried to insert the locking screws into holes not intended for such screws, such as k-wire holes or holes intended for cortex and cancellous screws only.As a reminder, the operative technique clearly state: ¿ locking screws cannot act as lag screws.Should an interfragmentary compression effect be required, a 4.0mm cancellous screw must first be placed in the plate prior to the placement of any locking screws ¿ (following the "lag before lock" principle as described in the ¿general guidelines¿ section).The threaded targeter attachment hole is for the exclusive use of connecting pin from the axsos tibia targeter instrument set and the aiming block set screw.No other screws shall ever be placed in this hole.The two holes distal to the threaded targeter attachment hole accept non-locking screws only.The most proximal shaft hole on the proximal medial tibia plate is non-locking.¿ 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 more information is provided, the case will be reassessed.

• Brand Name: LOCKING SCREW AXSOS 3 4.0MM / L70MM
• 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: 15611199
• Report Number: 0008031020-2022-00545
• Device Sequence Number: 7374791
• Product Code: HRS
• UDI-Device Identifier: 07613252579946
• UDI-Public: 07613252579946
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K123964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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: 661070
• Device Catalogue Number: 661070
• Device Lot Number: K32778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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: Male
• Patient Weight: 80 KG