MAUDE Adverse Event Report: STRYKER GMBH TITANIUM BONE SCREWS, CROSS-FIT, SELF-TAPPING, DIAM.2.3X10MM, (5/PCKG); PLATE, FIXATION, BONE

Model Number	59-23010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned; device was discarded.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported, "on (b)(6) 2020, at 9:00 a.M., the patient came to our hospital with a fracture of the right little finger for "right little finger incision and internal fixation." during the operation, the surgeon installed the steel plate, and fixed it with screws.During the process of tightening the screws, the screw cap partly broke and fractured, the broken part fell into the incision wound.Remove the broken part immediately with forceps, rinse the wound with saline, replace a screw and continue the procedure.During the subsequent installation of the screw, operate as gently as possible.This event resulted in prolonged operative time.(due to time constraints and the need for sterility during the operation, the broken screw was thrown into the medical waste bin during the operation without being photographed, and medical waste was cleaned up immediately after the operation to prepare for the next operation by the logistician)." additionally reported: delay one half an hour.Patient is hard bone.No additional anesthesia due to the delay.

• Brand Name: TITANIUM BONE SCREWS, CROSS-FIT, SELF-TAPPING, DIAM.2.3X10MM, (5/PCKG)
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10900761
• Report Number: 0008031020-2020-02530
• Device Sequence Number: 14088978
• Product Code: HRS
• UDI-Device Identifier: 34546540244865
• UDI-Public: 34546540244865
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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 Model Number: 59-23010
• Device Catalogue Number: 59-23010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1