MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNIVERSAL ROD, SHORT T2 HUMERUS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0113
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "when the t2h nail was attempted to removed, and extraction rod, conical t2 humerus and universal rod, short t2 humerus were connected, the connection part (tip part) of universal rod, short t2 humerus was broken.The operation was continued and completed without problem.".
Event or Problem Description
As reported: "when the t2h nail was attempted to removed, and extraction rod, conical t2 humerus and universal rod, short t2 humerus were connected, the connection part (tip part) of universal rod, short t2 humerus was broken.The operation was continued and completed without problem.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the universal rod was returned broken.The device inspection revealed the following: confirms the universal rod to be broken and the broken piece of the universal rod stuck inside the extraction rod.The pattern of the surface of the breakage point on the universal rod is consistent with an instant breakage due to excess load application.There are also signs of impact with hard material/object on the extraction rod.Functional inspection: due to the nature of the returned device, a functional inspection was not possible.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by excess load applied on the universal rod during insertion of assembled components for explantation of device.If any further information is provided, the complaint report will be updated.

• Brand Name: UNIVERSAL ROD, SHORT T2 HUMERUS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9718015
• Report Number: 0009610622-2020-00054
• Device Sequence Number: 2401357
• Product Code: LXH
• UDI-Device Identifier: 04546540196026
• UDI-Public: 04546540196026
• Combination Product (Y/N): N
• 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): 03/24/2020

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: 1806-0113
• Device Catalogue Number: 18060113
• Device Lot Number: K537754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1