MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X36MM TL12MM; SCREW, FIXATION, BONE

Catalog Number	604636S
Medical Device Problem Codes	Break (1069); Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "primary surgery was performed on (b)(6) 2023.Revision surgery for remove the implants due to bone union completed on (b)(6) 2024.During procedure, screw and extractor was fractured and remained in the patient body.The surgeon decide to remain these pieces in the patient, procedure was completed.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "primary surgery was performed on (b)(6) 2023.Revision surgery for remove the implants due to bone union completed on (b)(6) 2024.During procedure, screw and extractor was fractured and remained in the patient body.The surgeon decide to remain these pieces in the patient, procedure was completed.".
Additional Manufacturer Narrative
Please note corrections to section d4 lot# and d9, the device was not returned.The reported event could not be confirmed, since the device was not returned and no additional information was available.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X36MM TL12MM
• 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: 19197477
• Report Number: 0008031020-2024-00172
• Device Sequence Number: 8473971
• Product Code: HWC
• UDI-Device Identifier: 04546540089724
• UDI-Public: 04546540089724
• 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,Followup
• Report Date (Section B): 05/24/2024

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: 604636S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 05/24/2024
• 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
• Patient Sex: Unknown