MAUDE Adverse Event Report: STRYKER TRAUMA KIEL HUMERAL NAIL, AP T2 HUMERUS Ø8X220 MM; IMPLANT

Catalog Number 18301822S

Device Problems Positioning Failure (1158); Difficult to Insert (1316); Material Deformation (2976)

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

Event Date 11/22/2021

Event Type  malfunction  

Event Description

As reported: "the nail could not be inserted without strong hammering during nail insertion, and after insertion, the drill broke due to miss-targeting during proximal drilling.Since the drill tip was in the screw hole, the nail was extracted and deformation was observed in the devise connection of the nail." on 11/30/2021 additional information received: the procedure was completed successfully using the spare nail.No debris were left into the patient's body.

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.Therefore, it is subject to reportability under mdr.

Manufacturer Narrative

Please note corrections to section h6 device code.The reported event could be confirmed, since the device was returned for evaluation, and matches the alleged failure.The device inspection revealed the following: the visual inspection of the received t2 humeral nail reveals that it has a broken edge and shows hammering marks on the proximal part of the nail.Also, mis-drilling is evident in two holes of the nail.In one, the target device¿s drill target was outside the nail hole, however in other, the drill damaged the inner surface of the hole.However, as per functional inspection, the event could be confirmed as aggressive use of the slotted hammer as evident by the impact marks on the nail resulted in additional deformation leading to insertion impairment.In general, the nail should be advanced with manual pressure.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.The operative technique states that ¿gentle rotation of the nail may be necessary to start the nail insertion.The nail should be advanced with manual pressure.Aggressive use of the slotted hammer can result in additional fractures.If the nail does not advance easily, a check with image intensification should be made to see if the nail angle is too steep resulting in the nail impinging on the medial cortex.¿ based on investigation, the root cause was attributed to a primarily user related issue along with secondary factor such as patient¿s hard bone.The failure was caused due to hammering leading to deformation of nail at its proximal end, while simultaneously shifting the target of target device leading to mis-drilling.If any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "the nail could not be inserted without strong hammering during nail insertion, and after insertion, the drill broke due to miss-targeting during proximal drilling.Since the drill tip was in the screw hole, the nail was extracted and deformation was observed in the devise connection of the nail" 11/30/2021 - additional information received: the procedure was completed successfully using the spare nail.No debris were left into the patient's body.

• Brand Name: HUMERAL NAIL, AP T2 HUMERUS Ø8X220 MM
• Type of Device: IMPLANT
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13055899
• MDR Text Key: 284617897
• Report Number: 0009610622-2021-00824
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 18301822S
• Device Lot Number: K0D8D3F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2021
• 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