MAUDE Adverse Event Report: STRYKER GMBH DTD FEMUR RETROGRADE T2 ALPHA FEMUR RETROGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23533907
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
As reported: "t2 alpha femur retrograde distal targeting attachment malfunctioned and would not attach to nail holding jig unless great force was applied.Once attached - with great effort - it could not be removed.Could not utilize proximal targeting attachment, also had to acquire various additional x-ray angles to properly ascertain nail placement, since we could not remove distal targeting attachment.Both of these caused a prolonged procedure of 30 min.".
Event or Problem Description
As reported: "t2 alpha femur retrograde distal targeting attachment malfunctioned and would not attach to nail holding jig unless great force was applied.Once attached, with great effort, it could not be removed.Could not utilize proximal targeting attachment, also had to acquire various additional x-ray angles to properly ascertain nail placement, since we could not remove distal targeting attachment.Both of these caused a prolonged procedure of 30 min.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.Visual, functional and dimensional inspection was not possible due to missing item.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.Labelling requires lubrication of all movable parts after re-processing.No indications of material, manufacturing or design related problems were found during the investigation.In the case presented a patient should be treated using above target device which would not attach to nail holding jig unless great force was applied.Once attached, with great effort, it could not be removed.Those attempts had caused delay of approx.30 minutes which is within estimated risk assessment.With available information a real root cause could not be determined.It could not be figured out if lubrication was missing after re-processing.In case of a manufacturing issue the event would be covered by already filed nc.With available information a product deficiency was not verified.

• Brand Name: DTD FEMUR RETROGRADE T2 ALPHA FEMUR RETROGRADE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19710015
• Report Number: 0009610622-2024-00458
• Device Sequence Number: 15162488
• Product Code: HSB
• UDI-Device Identifier: 07613327411843
• UDI-Public: 07613327411843
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• 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): 09/30/2024

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: 23533907
• Device Lot Number: KP476521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown