MAUDE Adverse Event Report: Stryker GmbH 2.0MM, ASNIS MICRO, CANNULATED SCREW, 22/5MM, STERILE; Screw, Fixation, Bone

Catalog Number	40-20122S
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after k-wire insertion and measurement, drilling was performed.During screw insertion, a bone fragment fractured.Although the attempt to insert the screw was abandoned, the tip of the screwdriver broke off in the process.The broken fragment was retrieved and discarded.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.

• Brand Name: 2.0MM, ASNIS MICRO, CANNULATED SCREW, 22/5MM, STERILE
• Common Device Name: Screw, Fixation, Bone
• 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 ; +1(201)831-5000
• MDR Report Key: 50356597
• Report Number: 0008031020-2026-01262
• Device Sequence Number: 21390445
• Product Code: HWC
• UDI-Device Identifier: 04546540533364
• UDI-Public: 04546540533364
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 40-20122S
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown