MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X340MM X 130; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3430-1340S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Exsanguination (1841); Perforation (2001)
Date of Event	09/06/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
As reported: "i was made aware by another consultant of an event that occurred - where a gamma nail was implanted in the patient, however the tip-apex distance of the lag screw was wrong so the screw cut out and needed revision, patient started losing a large amount of blood and later was pronounced deceased in icu.The case and corresponding surgeon is now under investigation.".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X340MM X 130
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10871616
• Report Number: 0009610622-2020-00717
• Device Sequence Number: 19483363
• Product Code: HSB
• UDI-Device Identifier: 07613252273950
• UDI-Public: 07613252273950
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/19/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 3430-1340S
• Device Catalogue Number: 34301340S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/19/2020
• 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: Death