MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34250360S
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/24/2018
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.Sent to pathology.
Event or Problem Description
Patient had right gamma nail put in (b)(6) at another hospital for a left femur fracture and subsequently broke the distal end of femur.Patient had fracture and needed reoperation.
Additional Manufacturer Narrative
The reported event that long nail kit r1.5, ti, right gamma3® ø10x360mm x 125° was alleged of issue k-538 (bone fracture) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Event description states, ¿patient had right gamma nail put in 11/11 at another hospital for a left femur fracture and subsequently broke the distal end of femur.¿ as right gamma nail is used for left femur fracture, this indicates that a wrong nail geometry was chosen.Also, patient is a female of age 91 years, most probably with poor bone quality (osteoporotic), it resulted in a bone fracture.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.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
Patient had right gamma nail put in (b)(6) at another hospital for a left femur fracture and subsequently broke the distal end of femur.Patient had fracture and needed reoperation.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X360MM 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: 8176744
• Report Number: 0009610622-2018-01515
• Device Sequence Number: 1959433
• Product Code: HSB
• UDI-Device Identifier: 04546540375353
• UDI-Public: 04546540375353
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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 Expiration Date: 06/30/2023
• Device Catalogue Number: 34250360S
• Device Lot Number: K090791
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2018
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/29/2019
• 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
• Patient Weight: 72