MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - SPEEDLOCK SLEEVE 170; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13201117
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "during the confirmation of target accuracy, black debris was found coming from inside the device.The patient was under general anesthesia prior to skin cut, but the procedure was postponed to the following day.".
Event or Problem Description
As reported: "during the confirmation of target accuracy, black debris was found coming from inside the device.The patient was under general anesthesia prior to skin cut, but the procedure was postponed to the following day.".
Additional Manufacturer Narrative
The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned part was confirmed based on the catalog # and the lot # marked.The gamma3 - speedlock sleeve 170 shows clear signs of significant wear.The original white lettering has faded to a brownish hue and is marred by numerous scratches.Examination of the slotted holes reveals brittle and uneven edges, indicating material ageing.Flaking is visible in several places, and dents can be seen on the surface.These observations suggest that the component has been used frequently.Furthermore, the date of manufacture (2014) suggests that the part has been in use for over 11 years.Please note the following: gamma3 instruments instructions for use l22000067 rev ab: ¿end of life definition stryker t&e typically does not specify the maximum number of uses appropriate for a reusable medical device.When cleaned, sterilized and maintained according to the instructions provided within this document, the reusable medical device basically maintains its function and biocompatibility over the lifetime of the device.In addition, the useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device, see appendix 2 for further details.Please contact your stryker representative in case are usable device has reached the end of its serviceable life and a replacement is required." (original statements) the pr#(b)(4) encompasses the devices gamma3 - target device (pr#(b)(4)) and gamma3 - speedlock sleeve 170 (pr#(b)(4)).These instruments are specifically intended for use in the implantation of a gamma3 trochanter nail.During the accuracy check, black particles were observed.These particles were partially sharp-edged, which is indicative of force being applied and subsequent material chipping.The design of the instruments does not require the application of significant force during assembly.Reference to the operative technique for the gamma3 hip fracture nailing system provides detailed instructions for proper procedural assembly.Root cause determination observed intraoperative material debris can be attributed to both wear and tear of the components and improper use of the device.Due to substantial signs of wear present on the surfaces and boreholes of both instruments, the exact location of the broken-off material cannot be definitively determined.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.If more information is provided, the case will be reassessed.

• Brand Name: GAMMA3 - SPEEDLOCK SLEEVE 170
• 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: 24430740
• Report Number: 0008031020-2026-00238
• Device Sequence Number: 16028134
• Product Code: LXH
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 13201117
• Device Lot Number: KP357285
• Date Returned to Manufacturer: 01/29/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female