MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SELF-TAPPING COMPRESSION SCREW FIXOS Ø2.5MM / L28MM; SCREW, FIXATION, BONE

Catalog Number	SV28
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : part of the device remains in the patient, the rest was discarded.
Event or Problem Description
As reported: "fixos screw sv28 broke during surgery in a finger.Distal part was in the patient proximal part outside." the rest of the screw was left in the patient.
Additional Manufacturer Narrative
Please note the correction to h6 results code.The reported event could be confirmed, from the provided image.The reported product was not returned but an image was provided in which we can confirm the breakage, as only the distal end is visible.The proximal end and the head are not visible as they are still implanted in the patient.The defective part is required for the complete analysis.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.
Event or Problem Description
As reported: "fixos screw sv28 broke during surgery in a finger.Distal part was in the patient proximal part outside." the rest of the screw was left in the patient.

• Brand Name: CANNULATED SELF-TAPPING COMPRESSION SCREW FIXOS Ø2.5MM / L28MM
• 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: 18034807
• Report Number: 0008031020-2023-00374
• Device Sequence Number: 7419749
• Product Code: HWC
• UDI-Device Identifier: 07613252263722
• UDI-Public: 07613252263722
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K070039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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: SV28
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 21 YR
• Patient Sex: Female