MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW IMN SCREWS Ø5X35MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23605035S
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
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.H3 other text : 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 could not be confirmed.But in the context of current reported screw a non-intended used counterpart item could be confirmed based on lot code provided, only.As per event details ¿ the hospital operating room staff opened the wrong nail on the left and right side and inserted it.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.¿ however, the further reported adverse consequences could not be confirmed since evidence [e.G.X-ray images] are not provided and a further medical statement therefore impossible.Finally, the ifu clearly instructs: ¿the correct selection of the fracture fixation appliance is extremely important.Implants can be available in different versions, varying for example in length, diameter, angle, right-hand and left-hand versions, material and number of drilled holes.Failure to use the appropriate appliance for the fracture condition may accelerate clinical failure¿ every implant must be used in the correct anatomic location, consistent with accepted standards of internal fixation.¿ complementary information about the used counterpart could be found under the main investigation of the nail.Based on above and information available this is rather user related event, and it could not be excluded that its resulting consequence of non-intended use of counterpart nail implanted.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
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." 1/16/2024 - additional information received: another nail was inserted and surgery was completed successfully.

• Brand Name: LOCKING SCREW IMN SCREWS Ø5X35MM
• 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: 18608392
• Report Number: 0009610622-2024-00046
• Device Sequence Number: 21090791
• Product Code: HSB
• UDI-Device Identifier: 07613327366198
• UDI-Public: 07613327366198
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• 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): 07/08/2024

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: 23605035S
• Device Lot Number: K16F475
• 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: 06/11/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2023
• 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