MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ONE STEP CONICAL REAMER GAMMA3® Ø15.5X350 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13200011
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that, during a primary procedure on a left femur with a gamma nail, the 1-step reamer broke where it attaches to the drill.Another instrument set was available in the o.R.And the procedure was completed successfully with no delay.No adverse consequences were reported.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.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.However, based on the complaint history, some of the possible causes are: improper handling, inadequate re-cleaning/sterilization, normal wear etc.No deviations were found during review of the manufacturing and inspection documents (dhr).As the device had been in use for approx.14 years, it is assumed that it had fulfilled its tasks in former surgeries as intended.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Based on the above facts it can be ascertained that the root cause of the reported event is not related to a deficiency of the device.A review of the labeling did not indicate any abnormalities.Ifu states: ¿ensure that the drilling and cutting tools to be used are sharp; discard them if they are not.Never attempt to sharpen drilling and cutting tools!¿ if the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that, during a primary procedure on a left femur with a gamma nail, the 1-step reamer broke where it attaches to the drill.Another instrument set was available in the operating room and the procedure was completed successfully with no delay.No adverse consequences were reported.

• Brand Name: ONE STEP CONICAL REAMER GAMMA3® Ø15.5X350 MM
• 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: 8767254
• Report Number: 0009610622-2019-00529
• Device Sequence Number: 1708014
• Product Code: LXH
• UDI-Device Identifier: 04546540388940
• UDI-Public: 04546540388940
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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): 09/18/2019

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: 13200011
• Device Lot Number: K773586
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 103