MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 Ø3.5MM / L46MM; SCREW, FIXATION, BONE

Model Number	661446S
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	10/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported that: "a patient operated on for an anterior shoulder block, comes back to the to the clinic after several days, the practitioner notices that one of the screws put in place has broken, and it is clear that the that the graft is no longer maintained.Unmaintained graft requiring a surgical revision, with change of screw and graft." additional information received: non-union, but early screw breakage.Both screws are broken.
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was not returned for evaluation.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 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.H3 other text : device disposition unknown.
Event or Problem Description
The customer reported that: "a patient operated on for an anterior shoulder block, comes back to the to the clinic after several days, the practitioner notices that one of the screws put in place has broken, and it is clear that the that the graft is no longer maintained.Unmaintained graft requiring a surgical revision, with change of screw and graft." additional information received: non-union, but early screw breakage.Both screws are broken.

• Brand Name: CORTEX SCREW AXSOS 3 Ø3.5MM / L46MM
• 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: 15779667
• Report Number: 0008031020-2022-00600
• Device Sequence Number: 12431296
• Product Code: HWC
• UDI-Device Identifier: 04546540686459
• UDI-Public: 04546540686459
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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: 661446S
• Device Catalogue Number: 661446S
• Device Lot Number: H58283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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: 23 YR
• Patient Sex: Male
• Patient Weight: 110 KG