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

Model Number 4933-0-400

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2022

Event Type  malfunction  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.

Event Description

It was reported that there was a bifocal bone transport due to a septic tibia fracture previously treated with two plates.The resection was around 9cm and the surgeon decided to do two osteotomies.For this reason six bone transport rods were used.After the positioning of the frame, the length needed to be corrected, however, when the distal locking components were unlocked, (with red washers) they were not able to be locked again.This resulted in a 45 minute delay to the surgery.This was the first surgery with external fixator but not the first one for the patient.The patient was previously treated with two plates, which were removed due to septic pseudoarthrosis.After a resection the external fixator was applied for bone transport procedure.No problem for the patient until now.

Manufacturer Narrative

The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.Engineering reviewed the received information and noted: i can confirm that the three mentioned lot¿s (h32791 / h66392 / k36312) are in scope of the nc.A nc got launched as at the lower end of the bone transport strut the function is not given, inspection of the received information/evidences are done or will be done, in the proceedings of the nc.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that there was a bifocal bone transport due to a septic tibia fracture previously treated with two plates.The resection was around 9 cm and the surgeon decided to do two osteotomies.For this reason six bone transport rods were used.After the positioning of the frame, the length needed to be corrected, however, when the the distal locking components were unlocked, (with red washers) they were not able to be locked again.This resulted in a 45 minute delay to the surgery.This was the first surgery with external fixator but not the first one for the patient.The patient was previously treated with two plates, which were removed due to septic pseudoarthrosis.After a resection the external fixator was applied for bone transport procedure.No problem for the patient until now.

Event Description

It was reported that there was a bifocal bone transport due to a septic tibia fracture previously treated with two plates.The resection was around 9 cm and the surgeon decided to do two osteotomies.For this reason six bone transport rods were used.After the positioning of the frame, the length needed to be corrected, however, when the the distal locking components were unlocked, (with red washers) they were not able to be locked again.This resulted in a 45 minute delay to the surgery.This was the first surgery with external fixator but not the first one for the patient.The patient was previously treated with two plates, which were removed due to septic pseudoarthrosis.After a resection the external fixator was applied for bone transport procedure.No problem for the patient until now.

Manufacturer Narrative

Recall number added to h9.

• 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: 15880293
• MDR Text Key: 304474204
• Report Number: 0008031020-2022-00654
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07613327094640
• UDI-Public: 07613327094640
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K153377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4933-0-400
• Device Catalogue Number: 49330400
• Device Lot Number: H32791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1191-2023
• Patient Sequence Number: 1