MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECON KNOB T2 ALPHA FEMUR ANTEGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2353-3301
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded.
Event or Problem Description
As reported: "23533301 recon knob femur antegrade broke into three pieces during a pf nailing.The nail was being implanted using the mallet on the assembled jig with the strike plate attached.On one blow of the mallet a piece of the knob was seen to fly across the operating room approximately 2 metres.It is unclear to everyone in the room if the knob had come into contact with a clamp that was distal to the jig".

• Brand Name: RECON KNOB T2 ALPHA FEMUR ANTEGRADE
• 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: 9886646
• Report Number: 0009610622-2020-00125
• Device Sequence Number: 2804100
• Product Code: HSB
• UDI-Device Identifier: 07613327338638
• UDI-Public: 07613327338638
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K191271
• 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
• Report Date (Section B): 03/26/2020

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: 2353-3301
• Device Catalogue Number: 23533301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2020
• Initial Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1