MAUDE Adverse Event Report: STRYKER GMBH TRANSPORT STRUT HOFFMANN LRF; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	4933-0-400
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "patient came in for follow up on the bone transport frame.The surgeon then noticed the bt strut had malfunctioned and was no long moving or transporting.The other 2 struts did move making the transporting bone shift anterior to posterior.We were able to swap out the broken strut for another strut.The patient had to spend another hour in the clinic while we exchanged his strut and had to go back and get follow up x-rays." update: we used all stryker hoffman components.1 half ring, 3 circular rings and 1 foot plate with rocker shoes, 4 struts were used in total.The patient was instructed to keep weigh barring to a minimum.We added rocker shoes a week after in the clinic to help with allowing the patient to rest his foot on the ground.The overall health of the patient is good and bone quality was fine.The frames was attached to the patients tibia.Activity level of the patient was low.The patient did not complain.The surgeon noticed the struts not working correctly after x-rays were performed.
Additional Manufacturer Narrative
The reported event could not be confirmed, since doesn't matches the alleged failure, although the product was returned for evaluation.The optical and functional evaluation of the returned part shows that the part got returned in a used, but functional condition.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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.
Additional Manufacturer Narrative
Please note the corrections to h6 results and h6 conclusion codes.The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The optical and functional evaluation of the returned part shows that the part got returned in a strongly used, but functional condition.R&d has done first inspection and reviewed the received information and noted: there were samples which showed ¿deformations¿ which can be caused by one non-functioning strut in the frame construct.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.Based on investigation, the root cause was attributed to a non-functioning strut in the construct.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "patient came in for follow up on the bone transport frame.The surgeon then noticed the bt strut had malfunctioned and was no long moving or transporting.The other 2 struts did move making the transporting bone shift anterior to posterior.We were able to swap out the broken strut for another strut.The patient had to spend another hour in the clinic while we exchanged his strut and had to go back and get follow up x-rays." update: we used all stryker hoffman components.1 half ring, 3 circular rings and 1 foot plate with rocker shoes, 4 struts were used in total.The patient was instructed to keep weigh barring to a minimum.We added rocker shoes a week after in the clinic to help with allowing the patient to rest his foot on the ground.The overall health of the patient is good and bone quality was fine.The frames was attached to the patients tibia.Activity level of the patient was low.The patient did not complain.The surgeon noticed the struts not working correctly after x-rays were performed.

• Brand Name: TRANSPORT STRUT HOFFMANN LRF
• 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: 15825046
• Report Number: 0008031020-2022-00616
• Device Sequence Number: 6109392
• Product Code: KTT
• UDI-Device Identifier: 07613327094640
• UDI-Public: 07613327094640
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153377
• 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): 05/24/2023

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: Lay User/Patient
• Device Model Number: 4933-0-400
• Device Catalogue Number: 49330400
• Device Lot Number: D24256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2019
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 127 KG