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

Catalog Number	325036
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
He device will not be returned.When additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "a loaner instrument tray was brought by the stryker representative and sterilized for use by our csr team.Patient taken to operating room on (b)(6) 2025 and was undergoing a orif (open reduction internal fixation) of the right patellar.The orthopedic surgeon inserted a 4.0 36 cannulated screw into the right patella.The stryker vendor was present and the entire procedure was performed under fluoroscopy.When inserting, the surgeon noted a pulling sensation and noted that the screw appeared to be moving.Upon visualization 2 small threads of the screw were noted in the patella.One fragment was immediately removed along with the screw and the second could not be retrieved, per the surgeon, since it was imbedded in the bone.The remainder of the procedure (replacement screw inserted) proceeded without incident.The right knee was bandaged and placed in a knee immobilizer.The patient was recovered in pacu and transferred to a med/surg unit in stable condition.The patient was informed of the retained foreign body.She was medicated for pain prn".
Additional Manufacturer Narrative
Correction - please refer to h6 health code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "a loaner instrument tray was brought by the stryker representative and sterilized for use by our csr team.Patient taken to or on (b)(6) 2025 and was undergoing a orif (open reduction internal fixation) of the right patellar.The orthopedic surgeon inserted a 4.0 36 cannulated screw into the right patella.The stryker vendor was present and the entire procedure was performed under fluoroscopy.When inserting, the surgeon noted a pulling sensation and noted that the screw appeared to be moving.Upon visualization 2 small threads of the screw were noted in the patella.One fragment was immediately removed along with the screw and the second could not be retrieved, per the surgeon, since it was imbedded in the bone.The remainder of the procedure (replacement screw inserted) proceeded without incident.The right knee was bandaged and placed in a knee immobilizer.The patient was recovered in pacu and transferred to a med/surg unit in stable condition.The patient was informed of the retained foreign body.She was medicated for pain prn".

• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23030660
• Report Number: 0008031020-2025-01471
• Device Sequence Number: 9681877
• Product Code: HWC
• UDI-Device Identifier: 07613327077957
• UDI-Public: 07613327077957
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K220319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 325036
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown