MAUDE Adverse Event Report: STRYKER GMBH U-BLADE SET, TI GAMMA3 Ø10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 30650095S

Device Problems Device Difficult to Setup or Prepare (1487); Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 01/28/2022

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.

Event Description

As reported:"the u-blade did not enter through the distal end of the lag screw.The surgery was completed by tightening the end cap without inserting the u-blade.The patient is elderly and has fragile bone structure." there is a risk of cutout postoperatively.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidence were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

As reported:"the u-blade did not enter through the distal end of the lag screw.The surgery was completed by tightening the end cap without inserting the u-blade.The patient is elderly and has fragile bone structure." there is a risk of cutout postoperatively.

Event Description

As reported:"the u-blade did not enter through the distal end of the lag screw.The surgery was completed by tightening the end cap without inserting the u-blade.The patient is elderly and has fragile bone structure." there is a risk of cutout postoperatively.

Manufacturer Narrative

Please refer to d3 and h6 device code.

• Brand Name: U-BLADE SET, TI GAMMA3 Ø10.5X95MM
• Type of Device: 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: 13596061
• MDR Text Key: 287680108
• Report Number: 0009610622-2022-00071
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K043431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 30650095S
• Device Lot Number: K01D219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 03/30/2022; 09/26/2023
• Supplement Dates FDA Received: 04/27/2022; 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female