MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LAG SCREW REAMER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	14200240
Medical Device Problem Codes	Material Fragmentation (1261); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
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: "when using the lag screw drill, there was slight resistance, and when removing the drill bit, a metal-like fragment was adhering to it.".
Event or Problem Description
As reported: "when using the lag screw drill, there was slight resistance, and when removing the drill bit, a metal-like fragment was adhering to it.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was returned for evaluation, and the fragment was stated into the pouch, but could not be opened due to contamination.The received device was visually inspected and found to have heavy, evenly distributed scratches across the surface.These scratches were observed to be more than superficial, with slight penetration into the surface material.The scratches were particularly concentrated at the ends of the reamer's cutting flutes.We can also see nick marks and dent marks around the cutting flutes.The nature and circular pattern of the scratch marks suggest that a thin metallic wire or similar material may have been wrapped around the reamer under force, causing repeated contact and surface deformation.Additionally, a sealed pouch was returned containing a stated fragment.However, the pouch was not opened due to the high risk of contamination, and based on external visual observation, the fragment was not visible from the top of the pouch.For the appropriate functional inspection for resistance while drilling, the alleged targeting device is required.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, we could see heavy scratch nick marks visible on the device, but there was a high risk of contamination, and based on external visual observation, the fragment was not visible from the top of the pouch.If any additional information is provided, the investigation will be reassessed.

• Brand Name: GAMMA4 - LAG SCREW REAMER
• 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: 24661194
• Report Number: 0008031020-2026-00444
• Device Sequence Number: 9344463
• Product Code: LXH
• UDI-Device Identifier: 07613327510133
• UDI-Public: (01)07613327510133(10)KP532694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: 14200240
• Device Lot Number: KP532694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2025
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian