MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE 10X320MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2333-1032S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378); Implant Pain (4561)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded by hospital.
Event or Problem Description
The following was reported: the t2alpha gt nail was inserted on (b)(6) 2020.The patient was complaining of pain in the proximal femur when he visited the hospital in mid-(b)(6), and when the x-ray was checked, it was confirmed that the nail was broken.It was not a factor such as a fall, but (b)(6) 2021 re-operation was performed, the t2 alpha was pulled out, a long gamma was inserted, and another company's plate was inserted.
Additional Manufacturer Narrative
The reported event could not be confirmed since no product and no medical records, i.E.X-rays, had been provided.The review of manufacturing documents revealed no deviation in the manufacturing process.Required material properties had been confirmed prior to manufacturing.No nc/capa had been filed for the item in question.Potential revision had been considered in the risk management file with appropriate values not having been exceeded by this case.The labelling already informs about that a temporary implant requires sufficient bone consolidation in order to relieve the nail during the implantation period.The labelling points out that product damage must be avoided.No indications of material, manufacturing or design related deficiencies were found during document review.In the case presented a femoral nail gt, right t2 alpha femur antegrade ø10x320mm had broken after an alleged implantation period of roughly 5 months.The patient was revised with another kind of nail plus a plate.Further information was not 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.With available information a real root cause could not be determined.In case substantive information or the item itself becomes available we reserve the right to re-open the investigation with root cause assessment.
Event or Problem Description
The following was reported: the t2alpha gt nail was inserted on (b)(6) 2020.The patient was complaining of pain in the proximal femur when he visited the hospital in mid-(b)(6), and when the x-ray was checked, it was confirmed that the nail was broken.It was not a factor such as a fall, but (b)(6) 2021 re-operation was performed, the t2 alpha was pulled out, a long gamma was inserted, and another company's plate was inserted.

• Brand Name: FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE 10X320MM
• 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: 11825147
• Report Number: 0009610622-2021-00514
• Device Sequence Number: 4308336
• Product Code: HSB
• UDI-Device Identifier: 07613327285970
• UDI-Public: 07613327285970
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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 Model Number: 2333-1032S
• Device Catalogue Number: 23331032S
• Device Lot Number: K0D03B4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 08/27/2021
• 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