MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R, R1500 T2 FEMUR Ø12X340 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1828-1234S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	04/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
The customer reported the following issue: "postoperative loosening of the end cap occurred in a case of retrograde insertion of a t2 femoral nail." additional information received: revision surgery was performed due to the non-union one and a half years after the initial surgery.The loosened end cap was discovered during patient follow-up (x-rays) and was also removed at the time of revision on a half years after the initial surgery.
Event or Problem Description
The customer reported the following issue: "postoperative loosening of the end cap occurred in a case of retrograde insertion of a t2 femoral nail." additional information received: revision surgery was performed due to the non-union one and a half years after the initial surgery.The loosened end cap was discovered during patient follow-up (x-rays) and was also removed at the time of revision on a half years after the initial surgery.
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 as well as the affected device must be available in order to determine the root cause of the complaint event.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 more information is provided, the case will be reassessed.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: FEMORAL NAIL, A/R, R1500 T2 FEMUR Ø12X340 MM
• 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12976309
• Report Number: 0009610622-2021-00816
• Device Sequence Number: 17351026
• Product Code: HSB
• UDI-Device Identifier: 04546540200679
• UDI-Public: 04546540200679
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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: 11/30/2019
• Device Model Number: 1828-1234S
• Device Catalogue Number: 18281234S
• Device Lot Number: K04BF28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Weight: 100 KG