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 Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The locking mechanism for the moving ring derotation post on the medial side broke, a new strut was exchanged for the broken strut.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
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 device inspection revealed the following: visual examination of the returned transport strut shows that it is in a well used condition, with scratches, dents and deformation all over.Furthermore, the returned transport strut is not in the original length anymore and the distal transport strut is missing.After the functional test, we can confirm that the returned item works as intended.The total length of the returned transport strut was measured and it shows that the product is no longer 370.6mm but only 225mm.Quality assurance engineering reviewed the received information and noted: 1.The allegedly broken threaded rod 49330400-12 lot v01229 was manufactured according to specification, as well the hardness, which contributes significantly to the strength, is in the required specification.2.According to the surgical technique, the threaded strut can be shortened with the ¿rod cutter¿.An ¿end cap¿ is putted to the cut surface to prevent against injuries.That indicates that the threaded rod was shortened because the end cap was included.We reproduced this cut on a threaded strut and the cut surface showed the same structure as the part in question.For this reason, it can be concluded that the threaded rod was shortened on purpose.Furthermore, some parts are missing from the entire article 49330400 lot d31147 to be able to assess the case conclusively.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.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.If more information is provided, the case will be reassessed.
Event or Problem Description
The locking mechanism for the moving ring derotation post on the medial side broke, a new strut was exchanged for the broken strut.

• 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: 13910437
• Report Number: 0008031020-2022-00127
• Device Sequence Number: 17114379
• Product Code: KTT
• UDI-Device Identifier: 07613327094640
• UDI-Public: 07613327094640
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2022

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 Model Number: 4933-0-400
• Device Catalogue Number: 49330400
• Device Lot Number: D31147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male