MAUDE Adverse Event Report: STRYKER GMBH T2 - TARGETING ARM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18063212
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
Sales rep reported the following: "can you check the accuracy of the sight (ref.1806-3212) as we had a lot of problems with it? additional info: the aim for the posterior anterior screw was not correct." update received 17 jun 2025."can you get more clarification on when it states "can you check the accuracy of the sight (ref.1806-3212) as we had a lot of problems with it?"."the aim for the posterior anterior screw was not correct" the posterior anterior screw arrived next to the nail.How was the issue solved? e.G.Spare part, free-hand-technique the surgeon was lucky and was able to remove the screw.He didn't put it back in.".
Event or Problem Description
Sales rep reported the following: "can you check the accuracy of the sight (ref.1806-3212) as we had a lot of problems with it? additional info: the aim for the posterior anterior screw was not correct." update received 17 jun 2025."can you get more clarification on when it states "can you check the accuracy of the sight (ref.1806-3212) as we had a lot of problems with it?"."the aim for the posterior anterior screw was not correct" the posterior anterior screw arrived next to the nail.How was the issue solved? e.G.Spare part, free-hand-technique the surgeon was lucky and was able to remove the screw.He didn't put it back in.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and found to be functional in nature.The returned set targeting arm was received in overall good condition, with slight marks.We also see that the marking color is moved from white to fawn, which is caused by a high number of sterilization and cleaning cycles.A functional inspection was conducted with a sample nail adapter, nail, sleeve, drills, and it was checked at the lateral, medial, and posterior sections, and it was observed that the locking was working as it was intended.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.Based on the above investigation, the root cause can be attributed user related, as in the functional inspection device was found to be functional.If any additional information is provided, the investigation will be reassessed.

• Brand Name: T2 - TARGETING ARM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22287651
• Report Number: 0008031020-2025-00982
• Device Sequence Number: 8922083
• Product Code: LXH
• UDI-Device Identifier: 04546540708496
• UDI-Public: (01)04546540708496(11)200130(10)K0E3C97
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: 18063212
• Device Lot Number: KME912517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown