MAUDE Adverse Event Report: STRYKER TRAUMA KIEL K-WIRE, STERILE T2 FEMUR Ø3X285 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060050S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2019
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
It was reported that, during a primary procedure on a right ankle, the device was not opened as the outer sterile packaging was noted to have a hole in it.The hole was seen without opening the outer packaging.The device was not used and another device was available for immediate use.Surgery was completed with no delay.
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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.
Event or Problem Description
It was reported that, during a primary procedure on a right ankle, the device was not opened as the outer sterile packaging was noted to have a hole in it.The hole was seen without opening the outer packaging.The device was not used and another device was available for immediate use.Surgery was completed with no delay.

• Brand Name: K-WIRE, STERILE T2 FEMUR Ø3X285 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: 8631565
• Report Number: 0009610622-2019-00279
• Device Sequence Number: 1822263
• Product Code: LXH
• UDI-Device Identifier: 04546540195852
• UDI-Public: 04546540195852
• 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): 07/30/2019

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 Expiration Date: 01/31/2024
• Device Catalogue Number: 18060050S
• Device Lot Number: K0A828C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR