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

Catalog Number 23534113

Device Problems Residue After Decontamination (2325); Material Deformation (2976)

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

Event Date 11/15/2023

Event Type  malfunction  

Event Description

As reported: "detected metal chips in inserts for t2 alpha spi, after washing/cleaning.".

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device is retained by the hospital.

Event Description

As reported: "detected metal chips in inserts for t2 alpha spi, after washing/cleaning.".

Manufacturer Narrative

Please note corrections to section d9/h3; the device was returned, and h6 (device, method, results and conclusion codes).The reported event could be confirmed, since the reported "metal chips" can be confirmed.The device inspection revealed the following: the visual inspection of the nail interface at the nail adapter has shown that there are several strong deformations with some burrs are visible and that one of the prongs is slightly bent outwards.The nail adapter is in general in a very used condition, there are clearly visible stress marks at the targeting arm interface.The marks indicate that the device was previously intense used.Due to the previously described damage at the nail interface of the nail adapter it was impossible to attach a nail properly, the nail adapter is not functional as required anymore.The nail holding screws are functional as required, both devices could be inserted into the nail without any issues.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.Based on investigation, the root cause was attributed to a user related issue.The event was most likely caused by a loose connection between the nail and the adapter which did lead to a mechanical overload during use.In this relation following statement t2 alpha tibia instruments the instructions for use can be pointed out: ¿during the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.¿ if more information is provided, the case will be reassessed.

• Brand Name: NAIL ADAPTER TIBIA SPI T2 ALPHA? TIBIA
• 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: 18283059
• MDR Text Key: 329945125
• Report Number: 0009610622-2023-00441
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 23534113
• Device Lot Number: KME917775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2022
• 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