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	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
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.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem 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.
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Recall number added to h9.
Event or Problem 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 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.

• 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: 15880305
• Report Number: 0008031020-2022-00655
• Device Sequence Number: 12124061
• Product Code: KTT
• UDI-Device Identifier: 07613327094640
• UDI-Public: 07613327094640
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K153377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2023

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: Health Professional
• Device Model Number: 4933-0-400
• Device Catalogue Number: 49330400
• Device Lot Number: H66392
• 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: 11/03/2022
• Supplement Date Received by Manufacturer: 11/28/2022; 04/17/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 12/27/2022; 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1191-2023
• Patient Sequence Number: 1
• Patient Sex: Unknown