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

Model Number 1806-1402

Device Problem Mechanical Jam (2983)

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

Event Date 10/02/2021

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation, additional information will be provided in a supplemental report.

Event Description

It was reported that during implantation of a t2 tibial nail using the suprapatellar instrumentation the nail appeared to have gotten fused to the nail holding bolt and insertion arm.The staff spent 10-15 minutes attempting to disengage the nail but were unable to.They elected to use the standard approach with a new nail.The nail was able to be disengaged after it was returned to stryker (b)(4).

Manufacturer Narrative

The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode the device inspection revealed the following: the devices were returned in good condition.Slight deformation can be observed at the distal end where the nail connects.Fretting marks are observed in the underside distal region.While inserting the nail holding screw in the targeting arm sleeve slight resistance can be observed.Since both the targeting arm and nail holding screw have fretting marks it is possible that device got jammed by frictional welding.No indications of material, manufacturing or design related problems were found during the investigation.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.The instructions for use instructs user that: ¿ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments.¿ based on investigation, the root cause was attributed to a user related issue.The appearance of damage indicates that the devices were cold welded due to high surface pressure caused by assembly under misalignment.If any further information is provided, the complaint report will be updated.

Event Description

It was reported that during implantation of a t2 tibial nail using the suprapatellar instrumentation the nail appeared to have gotten fused to the nail holding bolt and insertion arm.The staff spent 10-15 minutes attempting to disengage the nail but were unable to.They elected to use the standard approach with a new nail.The nail was able to be disengaged after it was returned to stryker canada.

• Brand Name: NAIL ADAPTER T2 TIBIA SPI
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12785969
• MDR Text Key: 284386426
• Report Number: 0009610622-2021-00780
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327005387
• UDI-Public: 07613327005387
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131365
• 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: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1806-1402
• Device Catalogue Number: 18061402
• Device Lot Number: K0DE5A6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2020
• 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