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

Model Number	2353-4113
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2022
Type of Reportable Event	Malfunction
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: "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.".
Additional 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 surfaces at forefront of the nail adapter are in a good condition with no visible damages.In general is the device in a good condition with just very slight wear marks.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 or Problem 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 ADAPTER TIBIA SPI T2 ALPHA? TIBIA
• Common Device Name: 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: 14340611
• Report Number: 0009610622-2022-00177
• Device Sequence Number: 14773603
• Product Code: HSB
• UDI-Device Identifier: 07613327358018
• UDI-Public: 07613327358018
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• 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): 08/17/2022

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
• Operator of Device: Health Professional
• Device Model Number: 2353-4113
• Device Catalogue Number: 23534113
• Device Lot Number: KME916367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• 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
• Patient Sex: Unknown