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 Difficult to Open or Close (2921)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event 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.

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 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
• 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: 15876520
• MDR Text Key: 304457317
• Report Number: 0008031020-2022-00650
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07613327094640
• UDI-Public: 07613327094640
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K153377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

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: H30794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1