MAUDE Adverse Event Report: STRYKER GMBH LENGTHENER ASSEMBLY HOFFMANN II MICRO; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	49603000
Medical Device Problem Codes	Material Separation (1562); Use of Device Problem (1670)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "patient tried to do daily tightening of mini rail and noticed that the machine was not engaging.Within hours of this discovery, her foot became extremely swollen and she was admitted to the hospital.Hardware was switched out in her room, but the physician is not sure if they will need to revise yet or not.We are awaiting further imaging.".
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.H3 other text: device disposition is unknown.
Additional Manufacturer Narrative
Correction- please refer to h6 device code.The complaint could be confirmed, since the information for evaluation matches the alleged failure.The investigation revealed the following: an inspection of the images has shown that the instrument indeed fell apart, for further statement we need to receive the material back for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.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 must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "patient tried to do daily tightening of mini rail and noticed that the machine was not engaging.Within hours of this discovery, her foot became extremely swollen and she was admitted to the hospital.Hardware was switched out in her room, but the physician is not sure if they will need to revise yet or not.We are awaiting further imaging.".

• Brand Name: LENGTHENER ASSEMBLY HOFFMANN II MICRO
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 18981707
• Report Number: 0008031020-2024-00145
• Device Sequence Number: 6298985
• Product Code: KTT
• UDI-Device Identifier: 04546540492791
• UDI-Public: 04546540492791
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K052037
• 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): 07/12/2024

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: 49603000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR
• Patient Sex: Female