MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HANDLE T2 FEMUR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18061006
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2018
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
Broken impactor in targeting device.
Additional Manufacturer Narrative
The reported event that 1 nail handle t2 femur was alleged broken could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.This is the first reported case with this lot number, the device can be therefore confirmed faultless prior the distribution.A review of the labeling did not indicate any abnormalities.If device is returned or any further information is provided, the investigation report will be reassessed.Device was not received.
Event or Problem Description
Broken impactor in targeting device.

• Brand Name: NAIL HANDLE T2 FEMUR
• 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: 8182769
• Report Number: 0009610622-2018-01522
• Device Sequence Number: 2070351
• Product Code: LXH
• UDI-Device Identifier: 04546540196552
• UDI-Public: 04546540196552
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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: 18061006
• Device Lot Number: KP214690
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other