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

Model Number 4933-0-400

Device Problems Break (1069); Fracture (1260); Mechanical Jam (2983)

Patient Problem Failure of Implant (1924)

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event 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.".

Manufacturer Narrative

The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.Visual evaluation: the optical and functional evaluation of the returned part shows that the part got returned in a used condition and it got found that the part is not functional on the lower end.Dimensional inspection: the returned part got through dimensional inspection by production, the part meets all measurements.Inspection of the received information/evidences are done or will be done, in the proceedings of the nc.If more information is provided, the case will be reassessed.

Event 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.

Manufacturer Narrative

Recall number added to h9.

Event 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.

Event 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.

Manufacturer Narrative

The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.Visual evaluation: the optical and functional evaluation of the returned part shows that the part got returned in a used condition and it got found that the part is not functional on the lower end.Dimensional inspection: the returned part got through dimensional inspection by production, the part meats all measurements.Inspection of the received information/evidences are done or will be done, in the proceedings of the nc.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.If more information is provided, the case will be reassessed.

• Brand Name: TRANSPORT STRUT HOFFMANN LRF
• Type of Device: 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: 15274731
• MDR Text Key: 304305968
• Report Number: 0008031020-2022-00404
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07613327094640
• UDI-Public: 07613327094640
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/23/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 4933-0-400
• Device Catalogue Number: 49330400
• Device Lot Number: D40690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 10/25/2022; 04/17/2023; 04/26/2023
• Supplement Dates FDA Received: 11/22/2022; 04/17/2023; 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3152674
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 127 KG