MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X280MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-1280S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	08/11/2020
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.
Event or Problem Description
As reported, "in (b)(6) 2020, the patient suffered a subtrochanteric femur fracture on the right side, which was surgically treated with a gamma nail from stryker.The patient was then transferred from the marien krankenhaus hamburg to bg klinikum hamburg on (b)(6) 2020.There existed pain in the right femur for 5 days.(b)(6) shows a broken gamma- nail on the right.Trauma is not memorable.As a consequence a revision surgery had to be performed.Complex removal of the gamma nail and re-osteosynthesis.".
Additional Manufacturer Narrative
Correction: please refer to d4 (lot number).The reported event 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.The device history record could not be reviewed because the communicated lot number (koc3350) does not exist and the affected device was not returned to re-confirm the lot number.A review of the labeling did not indicate any abnormalities.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.However, the event states the trauma is not memorable.Taking in to consideration of past complaint history and current event, probable root cause would be but not limited to; patient factor (nonunion and traumatic overload), or user related (e.G.Implant was weakened / damaged when implanted, wrong nail geometry chosen, position of implant is incorrect, mislocking or misdrilling) etc.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "in (b)(6) 2020, the patient suffered a subtrochanteric femur fracture on the right side, which was surgically treated with a gamma nail from stryker.The patient was then transferred from the (b)(6).There existed pain in the right femur for 5 days.Nativ radiology shows a broken gamma- nail on the right.Trauma is not memorable.As a consequence a revision surgery had to be performed.Complex removal of the gamma nail and re-osteosynthesis.".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X280MM 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; GM D-24232
• MDR Report Key: 10805294
• Report Number: 0009610622-2020-00702
• Device Sequence Number: 11745298
• Product Code: HSB
• UDI-Device Identifier: 07613252273790
• UDI-Public: 07613252273790
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 3425-1280S
• Device Catalogue Number: 34251280S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 01/06/2021
• 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
• Patient Age: 72 YR