MAUDE Adverse Event Report: STRYKER GMBH ADVANCED LOCKING SCREW IMN SCREWS Ø5X35MM; SCREW, FIXATION, BONE

Model Number	2361-5035S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
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 discarded.
Event or Problem Description
As reported: "upon tightening the end cap and final confirmation with x-ray, a fracture line was discovered proximal to the most proximal locking screw.The surgeon considered preserving it as is, but because of the risk of re-fracture, he replaced the nail with a long nail that prepared as a backup." additionally it was reported that there was a 45 minute surgical delay.
Additional Manufacturer Narrative
Please note the correction to d3.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.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.With available information the root cause was attributed to a patient related issue; potentially contributed by the user.A product deficiency was not verified.
Event or Problem Description
As reported: "upon tightening the end cap and final confirmation with x-ray, a fracture line was discovered proximal to the most proximal locking screw.The surgeon considered preserving it as is, but because of the risk of re-fracture, he replaced the nail with a long nail that prepared as a backup." additionally it was reported that there was a 45 minute surgical delay.

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS Ø5X35MM
• 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: 17072922
• Report Number: 0009610622-2023-00194
• Device Sequence Number: 6095502
• Product Code: HWC
• UDI-Device Identifier: 07613327381597
• UDI-Public: 07613327381597
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2361-5035S
• Device Catalogue Number: 23615035S
• Device Lot Number: K09AAE6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian