MAUDE Adverse Event Report: Stryker GmbH IMN Instruments - Locking Drill D4.2x360mm; Orthopedic manual surgical instrument

Catalog Number	23514236S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the sales representative attended a gamma4 procedure at the facility.Both the implant and instrumentation were long-term loan products that had been stored by the hospital.Upon arrival, the surgeon had already selected the implant to be used, and the nail (gamma4 intermediate nail, right) had already been opened according to the surgeon's instruction.The instrumentation used in this system can be configured for either the right or left side.Based solely on the implant provided and without independently verifying the operative side of the patient, the sales representative instructed that the instrumentation be assembled in the right-side configuration.Compatibility checks between the instrumentation and drill were completed, and the procedure initially progressed without issue.During distal locking screw fixation, interference occurred between the nail and the drill, resulting in breakage of the drill tip within the nail hole.Removal of the broken drill fragment was difficult.As an alternative, the surgeon elected to place a locking screw in the most distal hole; however, interference occurred again during the subsequent drilling attempt.Because the degree of misalignment between the drill and the nail appeared unusually large, the label on the opened implant was reviewed.At that time, it was discovered that the operative side was the left femur, whereas the implanted nail was a right-sided implant.According to information obtained during follow-up, the surgeon had personally selected the implant before the sales representative arrived.The nurse handed the specified implant to the surgical team as instructed, and no implant verification or read-back procedure was performed prior to implantation.As a result, the right-sided nail was implanted for a left-sided procedure.The surgeon was informed of the laterality discrepancy.Despite the use of the incorrect-side implant, the surgeon determined that fixation remained acceptable because the medullary canal was sufficiently large and the implant had been successfully inserted.The targeting device was reattached, distal locking screw insertion was successfully completed, and the procedure was concluded.Based on the surgeon's clinical judgment, the right-sided implant was left in situ.Following the procedure, representatives of the hospital safety committee, nursing staff, and the distributor reviewed the event.As a corrective action, the facility agreed to implement a process requiring verbal confirmation and independent verification of implant information by multiple personnel before opening any implant package to prevent recurrence.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: IMN Instruments - Locking Drill D4.2x360mm
• 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 ; +1(201)831-5000
• MDR Report Key: 50841129
• Report Number: 0008031020-2026-01608
• Device Sequence Number: 10270697
• Product Code: LXH
• UDI-Device Identifier: 07613327350241
• UDI-Public: 07613327350241
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 23514236S
• Device Lot Number: K1B6061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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