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

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event 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.".

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 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
• Type of Device: 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
• MDR Text Key: 216601132
• Report Number: 0009610622-2020-00702
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613252273790
• UDI-Public: 07613252273790
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3425-1280S
• Device Catalogue Number: 34251280S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR