MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL HUMERAL NAIL LONG, RIGHT T2 PROX. HUM. Ø8X240 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18323824S
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device is implanted in patient.
Event or Problem Description
As reported: "ordering error by sales rep a proximal humeral long nail was incorrectly ordered and shipped for a humeral nail case.It was used without being noticed at the surgery." no patient impact reported.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.A review of the device history was not possible because the lot number was not communicated.No discrepancy of the product was reported.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation as the product had functioned to the satisfaction of the doctor.Local action between with representative and the surgeon to prevent recurrence has already been performed.Based on investigation, the root cause was attributed to a marketing related issue.If more information is provided, the case will be reassessed.With available information a product deficiency was not verified.
Event or Problem Description
As reported: "ordering error by sales rep.A proximal humeral long nail was incorrectly ordered and shipped for a humeral nail case.It was used without being noticed at the surgery." no patient impact reported.

• Brand Name: PROXIMAL HUMERAL NAIL LONG, RIGHT T2 PROX. HUM. Ø8X240 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 18887396
• Report Number: 0009610622-2024-00098
• Device Sequence Number: 15351089
• Product Code: HSB
• UDI-Device Identifier: 04546540437143
• UDI-Public: 04546540437143
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 18323824S
• Device Lot Number: K14B4B9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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
• Patient Sex: Unknown