MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X46MM TL15.5MM; SCREW, FIXATION, BONE

Model Number	604646S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned and no additional information was available.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.Body of screw remains in patient, head of the screw was discarded.
Event or Problem Description
As reported: "the asnis 4.0 was broken during removal surgery.The doctor attempted to remove the broken screw using the extractor for 4.0 mm diameter in the asnis 4.0 extraction set, but the tip of the extractor was also broken (chipped).The broken extractor tip was removed eventually.However, only the head of the screw could be removed and the doctor closed surgical incision while the thread part of the screw was left in the patient's body.Only the shaft of the extractor will be returned from the facility.Broken tip of the extractor and head of the screw were disposed at the hospital after removal.".

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X46MM TL15.5MM
• 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: 16628349
• Report Number: 0008031020-2023-00120
• Device Sequence Number: 4458202
• Product Code: HWC
• UDI-Device Identifier: 04546540089823
• UDI-Public: 04546540089823
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2023

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 Expiration Date: 03/31/2025
• Device Model Number: 604646S
• Device Catalogue Number: 604646S
• Device Lot Number: G21116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2020
• 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