MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III 4.0X46MM TL15.5MM; SCREW, FIXATION, BONE

Model Number	604646
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Half remains implanted; disposition of remainder of device is unknown.
Event or Problem Description
It was reported that during a left elbow dislocation fracture surgery the cannulated screw asnis 3, 4,0x46mm broke in 2 parts during insertion; the distal part remained fixed within the skeletal segment, its removal could have jeopardized the outcome of the surgery.Consequently, the screw had to be replaced, delaying the execution of the surgical procedure.The length of the delay has not been reported.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III 4.0X46MM TL15.5MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 12452597
• Report Number: 0008031020-2021-00407
• Device Sequence Number: 19817272
• Product Code: HWC
• UDI-Device Identifier: 04546540089816
• UDI-Public: 04546540089816
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K000080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/10/2021

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: 604646
• Device Catalogue Number: 604646
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1