MAUDE Adverse Event Report: STRYKER GMBH UNIVERSAL ROD T2 FEMUR Ø9 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0110
Medical Device Problem Codes	Break (1069); Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the instrument broke during explantation.Replacement was available.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the instrument broke during explantation.Replacement was available.".
Additional Manufacturer Narrative
Please note correction to h4 (manufacturing date).The reported event could be confirmed, since the device was returned, and matches the alleged failure.Device inspection revealed the following: the received universal rod was visually inspected in which we can see discoloration on the handle and scratch marks through the surface of the rod which indicate intensive usage over a period of time.We can see a material chip on the start of the cylindrical rod which indicates hitting.The tip is broken off the broken section was not returned; from the microscopic view, we can confirm that the breakage is brittle in nature smooth surface which was caused by the application of excessive rotational and bending force.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.Based on the investigation, the root cause was attributed to user-related, there was application of excessive rotational and bending force.If any additional information is provided, the investigation will be reassessed.
Additional Manufacturer Narrative
Please note correction to h6 (device code).
Event or Problem Description
As reported: "the instrument broke during explantation.Replacement was available.".

• Brand Name: UNIVERSAL ROD T2 FEMUR Ø9 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 17312247
• Report Number: 0009610622-2023-00251
• Device Sequence Number: 6506792
• Product Code: LXH
• UDI-Device Identifier: 04546540196019
• UDI-Public: 04546540196019
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2023

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 Model Number: 1806-0110
• Device Catalogue Number: 18060110
• Device Lot Number: K841429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 07/13/2023; 09/14/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/08/2023; 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown