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

Catalog Number	49330400
Medical Device Problem Codes	Use of Device Problem (1670); Mechanical Jam (2983)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "bone transport struts cut to transition to bone lengthening.After the cut below they piece could not get extracted.Case type: bone transport docking requesting further information on piece left in patient." the case was delayed by 20 minutes.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "bone transport struts cut to transition to bone lengthening.After the cut below they piece could not get extracted.Case type: bone transport docking.Requesting further information on piece left in patient." the case was delayed by 20 minutes.
Additional Manufacturer Narrative
Corrected fields: d4 (catalog and gtin number).The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the received material shows that only the distal ring with a bit of the rod of the transport strut got received, the other parts are missing.The received parts are in a used condition, as dents, deformation, scratches are visible.The rod has a straight cut and some small chips are visible at the end where the endcap was mounted, on the other side the rod got cut most likely with pliers (side cutters) as oblique deformation is visible.Furthermore, the rod has twice deformation at the outer diameter, opposite from each other, which is most likely the result of holding with pliers or a similar instrument.Functional examination of the received material shows that the received construct is completely jammed, with high applied force we were able to disassemble the received parts.After disassembling long chips got found inside the distal ring.Together with quality assurance engineering the received information and material got reviewed: a review of the manufacturing documents is not possible as the lot number was not communicated and is not visible on the part received.In addition, the procedure in production describes that every part (100%) has to be checked for his full function, for the full length, by final inspection.Furthermore, a part with these functional and visible damage would not pass finial inspection.The current operative technique state: warning: rod cutting must be performed before the time of surgery.Special attention should be paid during rod cutting so that debris or small components do not land in the surgical site.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.Based on investigation, the root cause was attributed to a use related issue.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "bone transport struts cut to transition to bone lengthening.After the cut below they piece could not get extracted.Case type: bone transport docking requesting further information on piece left in patient." the case was delayed by 20 minutes.

• 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: 20141102
• Report Number: 0008031020-2024-00473
• Device Sequence Number: 19639923
• Product Code: KTT
• UDI-Device Identifier: 07613327094640
• UDI-Public: 07613327094640
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K233741
• 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,Followup
• Report Date (Section B): 11/22/2024

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: Health Professional
• Device Catalogue Number: 49330400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 09/27/2024; 10/24/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/22/2024; 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown