MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR LEFT FEMUR 8 HOLE / L202MM; PLATE, FIXATION, BONE

Catalog Number	627608
Medical Device Problem Codes	Break (1069); Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
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.H3 other text : device discarded.
Event or Problem Description
As reported: "the patient had a non union roughly 1 year from orif surgery.The patient was revised with a non union take down and had a nail/plate combo for treatment during the revision surgery.".
Additional Manufacturer Narrative
Please note the corrections to b1, b5 and h6 device codes.The reported event could be confirmed, although the device was not returned but a couple of images and x-rays were shared which confirms the alleged event.The device was not received for investigation, however a couple of images were shared by the customer which shows the plate to be broken just below the broad segment at the level of the hole.No other images were shared which could help in identifying a definitive reason for breakage.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Since the device was not returned, it was not possible to determine the exact root cause of the issue.Although a couple of x-rays were shared but with the lack of patient data and other relevant event information, a sound clinical opinion could not be gathered, which could explain the reason for non-union at the first place.Most probable cause of the breakage of the plate could be the non-union, however for a definitive reason the device must be available for evaluation.The ifu clearly warns the user that: ¿the implant is intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.Regular postoperative examinations (e.G.X-ray checks) are advisable.The surgeon must warn patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or nonunion and that the device has a finite expected service life and may need to be removed at some time in the future.¿.[original statement(s)].If the device is returned or if any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "the patient had a non union roughly 1 year from orif surgery.The patient was revised with a non union take down and had a nail/plate combo for treatment during the revision surgery.".Update: x-rays show that the plate was broken.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR LEFT FEMUR 8 HOLE / L202MM
• 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: 18048623
• Report Number: 0008031020-2023-00377
• Device Sequence Number: 7499996
• Product Code: HRS
• UDI-Device Identifier: 07613252579564
• UDI-Public: 07613252579564
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K222381
• 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): 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 627608
• Device Lot Number: H46487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown