MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADVANCED LOCKING SCREW IMN SCREWS Ø5X50MM; SCREW, FIXATION, BONE

Model Number 2361-5050S

Device Problems Break (1069); Fracture (1260); Mechanical Jam (2983)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/19/2022

Event Type  malfunction  

Event Description

As reported: "during a t2 alpha gt procedure, an advanced locking screw was used, but it became stuck with the nail and could not be pulled out or advanced.It got stuck in the middle of insertion and could not be pulled out despite various attempts to remove it.The protruding part was crushed with a carbide drill as a last resort.The remainder of the screw was left in the body." additionally, it was reported that there was a 60 minute surgical delay.

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device remains implanted in the patient.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.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.In the case presented an advanced locking screw could not be positioned as intended.It rather became stuck half the way during insertion.The screw's hexagon and thread on the head became damaged during the procedure and could not be removed.A second screw had been placed proximally as intended.There was no allegation that the affected screw had broken.The manufacturing documents of the affected screw revealed no deficiency.The screw had left the premises as intended.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "during a t2 alpha gt procedure, an advanced locking screw was used, but it became stuck with the nail and could not be pulled out or advanced.It got stuck in the middle of insertion and could not be pulled out despite various attempts to remove it.The protruding part was crushed with a carbide drill as a last resort.The remainder of the screw was left in the body.".Additionally, it was reported that there was a 60 minute surgical delay.

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS Ø5X50MM
• Type of Device: SCREW, FIXATION, BONE
• 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: 15797423
• MDR Text Key: 307326096
• Report Number: 0009610622-2022-00505
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327381559
• UDI-Public: 07613327381559
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

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
• Device Operator: Health Professional
• Device Model Number: 2361-5050S
• Device Catalogue Number: 23615050S
• Device Lot Number: K04E430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 03/16/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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