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

Catalog Number	50485200
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/08/2024
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.H3 other text : device discarded by the customer.
Event or Problem Description
As reported: "hoffman compact mri was used on the first metatarsal foot at the primary surgery (b)(6) 2024.The rod was extended to the tibia and fixed.On (b)(6) 2024, the rod was broken near the middle due to the patient's fall.The rod is scheduled to be replaced with a new one on (b)(6) 2024 at the hospital ward.".
Event or Problem Description
As reported: "hoffman compact mri was used on the first metatarsal foot at the primary surgery on (b)(6) 2024.The rod was extended to the tibia and fixed.On 3/8/2024, the rod was broken near the middle due to the patient's fall.The rod is scheduled to be replaced with a new one on (b)(6) 2024 at the hospital ward.".
Additional Manufacturer Narrative
Corrections: please refer to h6 results and conclusion codes.The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.It got reported that the patient fall post-operative and that the part broke for that reason, the part got discarded.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.Based on the received information, the root cause was attributed to a patient factors issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• 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: 19039511
• Report Number: 0008031020-2024-00147
• Device Sequence Number: 8482456
• Product Code: KTT
• UDI-Device Identifier: 04546540492913
• UDI-Public: 04546540492913
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053038
• 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): 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: 50485200
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 04/04/2024
• 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): 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: Male