MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HOLDING SCREW TIBIA SPI T2 ALPHA? TIBIA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 2353-4114

Device Problem Mechanical Jam (2983)

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

Event Date 04/16/2022

Event Type  malfunction  

Event Description

As reported: "the surgeon inserted a 9mm t2 alpha tibia nail via the suprapatellar approach.Surgeon reamed to 10.5, and measured 320.He chose to use a 300 nail.The canal was narrow and the surgeon would have used an 8mm nail if available.Proximal screws and then distal screws were inserted.After distal screw insertion, surgeon was unable to detach nail holding bolt from the im rod.The surgeon spent 10 minutes trying to use the ball tip screw driver to disengage the bolt.He was unable to do so.Vice grips were eventually used to remove the screw.Force and counter force had to be use to disengage the screw from the rod and remove the nail adapter / nail holding bolt.".

Manufacturer Narrative

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

Manufacturer Narrative

The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the visual inspection has shown that the thread flanks at the forefront are worn and there are stress marks above the thread visible.Afterwards it cannot be defined if these damages occurred during the complained malfunction or previously.The performed function test has shown that the have no influence on the functionality.The top of the screw is badly damaged, obviously caused during the described forcible removal of the holding screw during the procedure.A function test with a nail was performed.It was possible to attach the nail adapter and to insert the nail holding screw, the screw could be tightened and loosened with the received ball tip screwdriver without any issues.The complained malfunction could not be reproduced.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.No indications of material, manufacturing or design related problems were found during the investigation.No product related issue could be detected, the received devices are functional as required.The root cause of the complained malfunction cannot be defined, based on the provided information that the canal was narrow it is possible that there was a high pressure on the devices, which could lead to increased loosening forces.If more information is provided, the case will be reassessed.

Event Description

As reported: "the surgeon inserted a 9mm t2 alpha tibia nail via the suprapatellar approach.Surgeon reamed to 10.5, and measured 320.He chose to use a 300 nail.The canal was narrow and the surgeon would have used an 8mm nail if available.Proximal screws and then distal screws were inserted.After distal screw insertion, surgeon was unable to detach nail holding bolt from the im rod.The surgeon spent ~10 minutes trying to use the ball tip screw driver to disengage the bolt.He was unable to do so.Vice grips were eventually used to remove the screw.Force and counter force had to be use to disengage the screw from the rod and remove the nail adapter / nail holding bolt.".

• Brand Name: NAIL HOLDING SCREW TIBIA SPI T2 ALPHA? TIBIA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 14340768
• MDR Text Key: 291720135
• Report Number: 0009610622-2022-00178
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327357981
• UDI-Public: 07613327357981
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191271
• 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: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2353-4114
• Device Catalogue Number: 23534114
• Device Lot Number: KP433903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1