MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL SLEEVE T2 TIBIA SPI Ø8-11, PTFE COATED; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1806-1408
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
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 by a rep that a surgeon tried to nail through metal.Unable to connect to handle thus the device is broken/bent.No further information is available.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the product was not returned for evaluation and no evidences were provided.The batch record could not be reviewed because the affected device was not returned and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.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 any additional information is provided, the investigation will be reassessed.Device disposition is unknown.
Event or Problem Description
Primary.It was reported by a rep that a surgeon tried to nail through metal.Unable to connect to handle thus the device is broken/bent.No further information is available.

• Brand Name: DRILL SLEEVE T2 TIBIA SPI Ø8-11, PTFE COATED
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9477664
• Report Number: 0009610622-2019-00970
• Device Sequence Number: 234175
• Product Code: HSB
• UDI-Device Identifier: 07613327005424
• UDI-Public: 07613327005424
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K131365
• 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): 01/27/2020

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: 1806-1408
• Device Catalogue Number: 18061408
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1