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

Model Number	1806-1005
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2020
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
The surgeon reported that during a t2 femoral nail procedure, he attached the jig and the proximal nail missed the jig.The surgeon completed the case free hand.There was a successful outcome but this resulted in a delay of 40 minutes the surgeon is concerned that the jig is wobbly on the nail.
Additional Manufacturer Narrative
Correction: refer to device availability.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.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.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.
Event or Problem Description
The surgeon reported that during a t2 femoral nail procedure, he attached the jig and the proximal nail missed the jig.The surgeon completed the case free hand.There was a successful outcome but this resulted in a delay of 40 minutes the surgeon is concerned that the jig is wobbly on the nail.

• Brand Name: TARGET DEVICE, FEMUR 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; DE D-24232
• MDR Report Key: 9890950
• Report Number: 0009610622-2020-00127
• Device Sequence Number: 14213250
• Product Code: LXH
• UDI-Device Identifier: 04546540196545
• UDI-Public: 04546540196545
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 06/11/2020

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: 1806-1005
• Device Catalogue Number: 18061005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1