MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X40MM TL13.5MM; SCREW, FIXATION, BONE

Model Number	604640S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Sales rep reported that : "following a ttat (transposition of the tuberosity of the anterior tibia) on a 16-year-old adolescent (52kg), the 2 asnis 4mm diameter screws broke." a revision surgery has been planned.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device remains implanted in patient.
Event or Problem Description
Sales rep reported that : "following a ttat (transposition of the tuberosity of the anterior tibia) on a 16-year-old adolescent (52kg), the 2 asnis 4mm diameter screws broke." a revision surgery has been planned.
Additional Manufacturer Narrative
The reported event could be confirmed from the available radiograph.With the available radiograph, a formal medical opinion was sought: without additional clinical and radiographic information from the surgery itself or early postoperative imaging, we cannot draw conclusions about the correctness of the treatment approach however the osteotomy did not successfully heal (non-union), which is likely to lead to failure of the device in any scenario.This is because the patellar tendon's tension on the bone fragment creates an ongoing significant mechanical load on the device.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X40MM TL13.5MM
• 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: 17304857
• Report Number: 0008031020-2023-00277
• Device Sequence Number: 17768740
• Product Code: HWC
• UDI-Device Identifier: 04546540089762
• UDI-Public: 04546540089762
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K213199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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: Lay User/Patient
• Device Model Number: 604640S
• Device Catalogue Number: 604640S
• Device Lot Number: C16648
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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 Age: 16 YR
• Patient Sex: Unknown
• Patient Weight: 52 KG