MAUDE Adverse Event Report: STRYKER GMBH ADVANCED LOCKING SCREW IMN SCREWS Ø5X70MM; SCREW, FIXATION, BONE

Catalog Number	23615070S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "rep was notified that at 6-month post-op follow-up for a left alpha tibial nail, the proximal advanced locking screw was broken in half.As there are other screws holding the nail, and the bone fracture (which the nail was implanted to address) is healing, the surgeon has no current plan to revise the nail until/ unless any adverse affect occurs with the patient.At time of report, rep was not made aware of any patient complaints.".
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report h3 other text : the device remains implanted in the patient.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and based on x-ray images available, the reported event of ¿¿the proximal advanced locking screw was broken in half¿¿ could not be verified; and confirmed by hcp as well.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: "rep was notified that at 6-month post-op follow-up for a left alpha tibial nail, the proximal advanced locking screw was broken in half.As there are other screws holding the nail, and the bone fracture (which the nail was implanted to address) is healing, the surgeon has no current plan to revise the nail until/ unless any adverse affect occurs with the patient.At time of report, rep was not made aware of any patient complaints.".

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS Ø5X70MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18917774
• Report Number: 0009610622-2024-00102
• Device Sequence Number: 6760058
• Product Code: HWC
• UDI-Device Identifier: 07613327381504
• UDI-Public: 07613327381504
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K193308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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 Catalogue Number: 23615070S
• Device Lot Number: K10E7FB
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• 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: Other; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male