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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
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
As reported: "we have had a case today where the drill and screw missed the posterior locking hole of the nail through the jig.The jig was also stiff to lock into the posterior locking hole." further information from rep received: "the surgeon redrilled for talus screw and screw then went in fine.Surgeon did not use the posterior screw as it kept missing the hole in the nail through the jig.The jig was stiff but it would still locking into position.".
Event or Problem Description
As reported: "we have had a case today where the drill and screw missed the posterior locking hole of the nail through the jig.The jig was also stiff to lock into the posterior locking hole." further information from rep received: "the surgeon redrilled for talus screw and screw then went in fine.Surgeon did not use the posterior screw as it kept missing the hole in the nail through the jig.The jig was stiff but it would still locking into position.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was returned for evaluation and found functional with respect to the alleged failure.The device inspection revealed the following: all the devices were received and found in good condition, free from any major dent, damage or deformation with respect to the alleged failure.Usage marks and discoloration of the devices suggest that the devices are significantly used devices.A functional inspection with the returned devices was done using a sample nail which indicates that the devices are functional with respect to the alleged failure, the drill sleeve aligns perfectly with the posterior locking hole of the sample nail, therefore the event stands not confirmed.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 investigation, the root cause cannot be determined since the event could not be confirmed during functional inspection.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 GMBH; 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: 24283906
• Report Number: 0008031020-2026-00134
• Device Sequence Number: 8319073
• Product Code: LXH
• UDI-Device Identifier: 04546540708496
• UDI-Public: 04546540708496
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/27/2026

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: KME901534
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2008
• 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