MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW IMN SCREWS Ø5X25MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23605025S
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "during a trauma surgery with t2 alpha tibia nail, 3 locking screws have been exchanged while suspected to be packed with the wrong specs.Length does not match with the perception of the surgeon.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "during a trauma surgery with t2 alpha tibia nail, 3 locking screws have been exchanged while suspected to be packed with the wrong specs.Length does not match with the perception of the surgeon.".
Additional Manufacturer Narrative
Correction - please refer to d9 - the product was not returned.The reported event could not be confirmed, since the affected device was not returned and other evidence were not shared for evaluation.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information as well as the affected device in the original packaging must be available in order to determine the exact root cause of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Additional Manufacturer Narrative
Correction - the product was not returned.
Event or Problem Description
As reported: "during a trauma surgery with t2 alpha tibia nail, 3 locking screws have been exchanged while suspected to be packed with the wrong specs.Length does not match with the perception of the surgeon.".

• Brand Name: LOCKING SCREW IMN SCREWS Ø5X25MM
• 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: 19514950
• Report Number: 0009610622-2024-00278
• Device Sequence Number: 7326201
• Product Code: HSB
• UDI-Device Identifier: 07613327366143
• UDI-Public: 07613327366143
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 11/20/2024

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: 23605025S
• Device Lot Number: K184F8D
• 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: 05/17/2024
• Supplement Date Received by Manufacturer: 07/18/2024; 10/23/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 08/14/2024; 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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