MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, FULLY THREADED ASNIS III Ø4.0X46MM; SCREW, FIXATION, BONE

Catalog Number	604746S
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the customer planned to implant an asnis iii 4.0mm screw, but the screwdriver in their 4.0mm kit didn't fit in the screw head.So they opened the asnis 5.0mm instrument, tray took out the belonging screwdriver for asnis 5.0mm screw and implanted the screw with this screwdriver.Since they could implant the opened screw with the screwdriver from 5.0mm instr.Set, they believe that it was a screw with correct length but that it was a 5.0mm screw packed in a implant box for 4.0mm.".
Additional Manufacturer Narrative
The reported event could not be confirmed.A x-ray showing the implanted screw was returned, however, it does not give enough evidence to confirm the reported event and determine a possible root cause.The affected device or further evidence would have been necessary.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: CANNULATED SCREW, FULLY THREADED ASNIS III Ø4.0X46MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18836681
• Report Number: 0008031020-2024-00112
• Device Sequence Number: 7214925
• Product Code: HWC
• UDI-Device Identifier: 04546540090195
• UDI-Public: 04546540090195
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K213199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/05/2024

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: 604746S
• Device Lot Number: AB5092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• 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
• Patient Sex: Unknown