MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X340MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	33250340S
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device was discarded.
Event or Problem Description
The doctor reported to sales rep that a patient did a revision surgery due to fact the first nail had been broken after 2-3 months after primary surgery.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X340MM X 125°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8223906
• Report Number: 0009610622-2019-00005
• Device Sequence Number: 11161068
• Product Code: HSB
• UDI-Device Identifier: 07613153313496
• UDI-Public: 07613153313496
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K034002
• 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
• Report Date (Section B): 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 33250340S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/07/2019
• 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: Required Intervention