MAUDE Adverse Event Report: STRYKER GMBH INTERMEDIATE NAIL, RIGHT D10X240MMX125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	82250240S
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "surgery for fracture of left femoral condyle.The hospital operating room staff opened the wrong nail on the left and right side and inserted it without realizing the mistake.After insertion, the staff did not notice the mistake and continued the procedure.When they attempted to insert the locking screw, it did not go in properly, resulting in a femoral diaphyseal fracture.Subsequent confirmation revealed that the wrong nail had been inserted on the left and right side.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device discarded by the hospital.
Event or Problem Description
As reported: "surgery for fracture of left femoral condyle.The hospital operating room staff opened the wrong nail on the left and right side and inserted it without realizing the mistake.After insertion, the staff did not notice the mistake and continued the procedure.When they attempted to insert the locking screw, it did not go in properly, resulting in a femoral diaphyseal fracture.Subsequent confirmation revealed that the wrong nail had been inserted on the left and right side.".
Additional Manufacturer Narrative
The reported event of non-intended used item could be confirmed based on lot code provided, only.The dhr review revealed the label to be printed as specified.It clearly identifies the nail with the catalogue number 82250240s and with the description as intermediate nail, right d10x240mmx125deg.As per event details "¿the hospital operating room staff opened the wrong nail on the left and right side and inserted it¿" however, the further reported adverse consequences "¿the femoral diaphysis was fractured during screw insertion due to insertion of the wrong nail on the left and right side¿" could not be confirmed since evidence [e.G.X-ray images] are not provided and a further medical statement therefore impossible.Finally, the labelling step was performed as intended and the label contained all the information as specified.The use of a wrong product is beyond the manufacturer's control.Based on above and information available this is a clear user related event and has to be classified as "user related event - not product related".A review of the device history for the reported lot did not indicate any abnormalities.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.

• Brand Name: INTERMEDIATE NAIL, RIGHT D10X240MMX125DEG
• 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: 18608377
• Report Number: 0009610622-2024-00045
• Device Sequence Number: 9128085
• Product Code: HSB
• UDI-Device Identifier: 07613327593723
• UDI-Public: 07613327593723
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 82250240S
• Device Lot Number: K1776E6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown