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
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/13/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
The reported event could not be confirmed since no product and no medical records, i.E.X-rays, had been provided.Review of dhr, complaint history, capa databases and risk analysis did not identify any discrepancies.The labelling informs about protentional adverse effects.Following the event description, displaced fracture after surgery, it was concluded that bone fragments had moved in some direction and for unknown reasons.With available information, a real root cause could not be defined.Since an intra-operative event was not excluded by the reporter it was concluded that the event was mainly caused by the user.In case substantive information or the item itself becomes available we reserve the right to re-open the investigation with root cause assessment.
Event or Problem 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
• Common Device Name: 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
• Report Number: 0009610622-2021-00813
• Device Sequence Number: 4883833
• Product Code: HSB
• UDI-Device Identifier: 04546540515414
• UDI-Public: 04546540515414
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K042396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2023
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male