MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 HUMERUS Ø4X34 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1896-4024S

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted.

Event Description

It was reported a revision of the surgery performed about a year ago was scheduled due to confirmed postoperative screw fracture.However, before the revision, a mistake in ordering the instruments was discovered and the surgery was postponed.The patient was under general anesthesia.Revision surgery was rescheduled for (b)(6) 2021.This record captures the postoperative screw fracture.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned, and no other evidence 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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported a revision of the surgery performed about a year ago was scheduled due to confirmed postoperative screw fracture.However, before the revision, a mistake in ordering the instruments was discovered and the surgery was postponed.The patient was under general anesthesia.Revision surgery was rescheduled for (b)(6) 2021.This record captures the postoperative screw fracture.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 HUMERUS Ø4X34 MM
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12478320
• MDR Text Key: 271667349
• Report Number: 0009610622-2021-00692
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540202307
• UDI-Public: 04546540202307
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K003018
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1896-4024S
• Device Catalogue Number: 18964034S
• Device Lot Number: K0866D6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Race: Asian