MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADVANCED LOCKING SCREW IMN SCREWS Ø5X65MM; SCREW, FIXATION, BONE

Model Number 2361-5065S

Device Problem Mechanical Jam (2983)

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

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

Device is not accessible.If additional information becomes available, it will be provided in a supplemental report.

Event Description

T2 alpha advanced locking screw was cold welded to the nail.Eventually it was able to be removed, and was replaced with a standard locking screw.Additionally, it was reported; the procedure was delayed but the length of the delay is unknown.

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS Ø5X65MM
• 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: 13964480
• MDR Text Key: 288875189
• Report Number: 0009610622-2022-00111
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327381634
• UDI-Public: 07613327381634
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2022

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
• Device Operator: Health Professional
• Device Model Number: 2361-5065S
• Device Catalogue Number: 23615065S
• Device Lot Number: K0208B4
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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