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

Catalog Number	18060143
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
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
A missdrilling in proximal occurred.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and is fully functional.The device inspection revealed the following: visual inspection: the received target device, humerus t2 humerus shows normal traces of use.The printings on the target device were turned from white to fawn; an indication for a high level of sterilization cycles.Apart from that, the device is in general good condition and further significant damage was not observed.Functional inspection: a pre-surgical function test (¿pre-operative check¿) with the returned target device, humerus t2 humerus and sample devices was performed.The drill can pass easily in the oblique locking static and straight locking dynamic so the alleged miss drilling in proximal could not be reproduced.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation performed, the root cause was attributed to a user related issue.The failure was caused by user-learning gap errors lack of knowledge/skill.If any further information is provided, the complaint report will be updated.
Event or Problem Description
A missdrilling in proximal occurred.

• 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
• MDR Report Key: 8928307
• Report Number: 0009610622-2019-00626
• Device Sequence Number: 2129128
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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 Catalogue Number: 18060143
• Device Lot Number: KME907096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1