MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE, HUMERUS T2 HUMERUS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0143
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported, after drilling the oblique hole, the surgeon could not insert the distal screw into screw hole well.After the surgeon drilled the hole again and tried to insert the screw sometime, succeeded to insert.
Event or Problem Description
It was reported, after drilling the oblique hole, the surgeon could not insert the distal screw into screw hole well.After the surgeon drilled the hole again and tried to insert the screw sometime, succeeded to insert.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Additionally, it was reported, the device was not returned for evaluation since the device was sent to the distribution center in japan where it was considered functional.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.

• Brand Name: TARGET DEVICE, HUMERUS 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: 9513701
• Report Number: 0009610622-2019-00982
• Device Sequence Number: 16803838
• Product Code: LXH
• UDI-Device Identifier: 04546540196071
• UDI-Public: 04546540196071
• 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): 02/26/2020

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: 1806-0143
• Device Catalogue Number: 18060143
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1