MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - INTERMEDIATE TARGETING SLEEVE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	14202100
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: "jig failed to target distal holes in gamma nail.Jig does not smoothly slide on gamma nailing target.Seems to not lock properly, lead to missdrilling.After the case, used a sample nail, triple sleeves and determined locking knob may be defective.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed.The inspection revealed the following: the identification of the returned part was confirmed based on the catalog number and the lot number marked.The gamma4 - intermediate targeting sleeve is in very good condition.There are no visible signs of damage, scratches or other wear and tear.The lettering is also in very good condition.The functional test was carried out using a sample gamma 4 proximal targeting arm (catalog 1420-0100) and the gamma4 - intermediate targeting sleeve (catalog 1420-2100) from a similar previous complaint.The sleeve locked onto the targeting arm without difficulty; the click in the correct position could be heard.The grey knob also functions perfectly and can be locked and unlocked.The functional test was also carried out using a sample intermediate targeting sleeve.No difference in functionality was observed compared to the part from the complaint.The function is fully operational and as described in the operative technique for the gamma4 hip fracture nailing system.Please note the following: gamma4 hip fracture nailing system operative technique: "assembly of intermediate targeting sleeve for distal locking of the intermediate nail, a dedicated intermediate targeting sleeve is required (fig.116).First, disassemble the targeting sleeve by releasing the knob, aligning the arrows of the proximal targeting arm and targeting sleeve and pulling.Then, assemble the intermediate targeting sleeve on the proximal targeting arm.A click will be felt when the intermediate targeting sleeve is correctly positioned.Tighten the fixation knob clockwiseto secure." [original statements].The root cause of the reported event is rather user related and has to be classified as user-customer-learning gap errors; lack of knowledge/skill.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
It was reported: "jig failed to target distal holes in gamma nail.Jig does not smoothly slide on gamma nailing targeter.Seems to not lock properly, lead to missdrilling.After the case, used a sample nail, triple sleeves and determined locking knob may be defective.

• Brand Name: GAMMA4 - INTERMEDIATE TARGETING SLEEVE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24222626
• Report Number: 0008031020-2026-00106
• Device Sequence Number: 8326164
• Product Code: HSB
• UDI-Device Identifier: 07613327591477
• UDI-Public: 07613327591477
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K230512
• 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): 04/27/2026

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: 14202100
• Device Lot Number: KP505117
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2023
• 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