MAUDE Adverse Event Report: STRYKER GMBH CONNECTING ROD HOFFMANN II COMPACT MRI Ø5X200MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	5048-5-200
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/30/2022
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.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: "fracture of a hoffmann fixator rod already in place on the patient's foot 4 days after application (application (b)(6) 2022).Fracture directly at the connector.Rod had to be replaced in revision surgery on (b)(6) 2022.".
Additional Manufacturer Narrative
Correction - please refer to h6 clinical code.The complaint could be confirmed, since the information for evaluation matches the alleged failure.The device inspection revealed the following: a device inspection was not possible since the affected device was not returned for investigation.An inspection of the images has shown that a broken rod is visible, article and lot number is not visible, further statements are not possible without the material.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 catalog number and lot number were 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: "fracture of a hoffmann fixator rod already in place on the patient's foot 4 days after application (application (b)(6) 2022).Fracture directly at the connector.Rod had to be replaced in revision surgery on (b)(6) 2022.".

• Brand Name: CONNECTING ROD HOFFMANN II COMPACT MRI Ø5X200MM
• 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: 16017979
• Report Number: 0008031020-2022-00698
• Device Sequence Number: 6656262
• Product Code: KTT
• UDI-Device Identifier: 04546540492913
• UDI-Public: 04546540492913
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K053038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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 Model Number: 5048-5-200
• Device Catalogue Number: 50485200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 49 YR
• Patient Sex: Male