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	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that during a hands on demonstration it was noted that the affected bone transport strut did not seem to be able to reach it's maximum length, even when quick lock mechanisms were both disengaged.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure.Visual inspection: after taking a closer look at the rod transport strut, it was detected that blows and deformations are visible on the thread.It cannot be confirmed whether the product was damaged in the hospital during reprocessing or elsewhere.The source of the deformations cannot be clearly confirmed.A fall to the floor could be a possible cause.Quality assurance engineering reviewed the received information and noted: the repeated measurement result measured crosswise, showed that all masses of the thread core are within the required drawing tolerance.The previous measurements were taken over the damaged areas of the thread, which explains the difference between 1.And 2.Investigation.Furthermore, it was determined that the error pattern is identical to pi3085323.Thus, it can be stated that not only the violations of the thread, but also the pitch (2mm), which varies between 1.99 and 2.08, leads to a jamming of the sleeve, although the pitch is within the required specification.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 or Problem Description
It was reported that during a hands on demonstration it was noted that the affected bone transport strut did not seem to be able to reach it's maximum length, even when quick lock mechanisms were both disengaged.

• 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: 15876520
• Report Number: 0008031020-2022-00650
• Device Sequence Number: 19462429
• Product Code: KTT
• UDI-Device Identifier: 07613327094640
• UDI-Public: 07613327094640
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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: H30794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2021
• 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 Sex: Unknown