MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X400MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3430-1400S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	09/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Device disposition is unknown.
Event or Problem Description
It was reported by the attorney, through the filing of a lawsuit, that the plaintiff underwent surgery at (b)(6) hospital in (b)(6) on (b)(6) 2018 to treat a broken femur.The doctor performed the surgery during which time a ¿stryker pin¿ was used.The plaintiff alleges that on (b)(6) 2018, the ¿pin¿ broke.The plaintiff alleges she underwent a surgery on (b)(6) 2018 at (b)(6) medical center during which time the pin was removed and plaintiff was converted to having a total hip replacement.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event such as the patient's details, his activity level post op, x-rays, as well as the affected device must be available in order to determine the root cause of the complaint event.Due to insufficient information the exact root cause could not be determined.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported by the attorney, through the filing of a lawsuit, that the plaintiff underwent surgery at (b)(6) hospital in (b)(6) on (b)(6) 2018 to treat a broken femur.The doctor performed the surgery during which time a ¿stryker pin¿ was used.The plaintiff alleges that on 9/1/18, the ¿pin¿ broke.The plaintiff alleges she underwent a surgery on 11/11/18 at baptist medical center during which time the pin was removed and plaintiff was converted to having a total hip replacement.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X400MM 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; DE D-24232
• MDR Report Key: 9372357
• Report Number: 0009610622-2019-00941
• Device Sequence Number: 14009297
• Product Code: HSB
• UDI-Device Identifier: 07613252274032
• UDI-Public: 07613252274032
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2021
• Device Model Number: 3430-1400S
• Device Catalogue Number: 34301400S
• Device Lot Number: K071F15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/28/2020
• 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: Required Intervention