MAUDE Adverse Event Report: STRYKER TRAUMA KIEL PROXIMAL HUMERAL NAIL, CANNULATED, LEFT T2 PROX. HUM. Ø8 X 150 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1832-1035S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 11/13/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device is not available; hospital retained.

Event Description

It was reported that the patient's left humerus was revised one day post-implant due to the proximal aspect of the humeral nail coming out of the proximal humerus. The patient's humeral fracture was noted to be displaced. It is not known if an intraoperative event the day previous was a cause or contributor to the failure. Revision performed, the nail was removed and a humeral plate was implanted.

• Brand Name: PROXIMAL HUMERAL NAIL, CANNULATED, LEFT T2 PROX. HUM. Ø8 X 150 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12975105
• MDR Text Key: 282035750
• Report Number: 0009610622-2021-00813
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540515414
• UDI-Public: 04546540515414
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1832-1035S
• Device Catalogue Number: 18321035S
• Device Lot Number: K0636C1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/10/2021 Patient Sequence Number: 1