MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X340MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 34250340S

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Implant Pain (4561)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by manufacturer? retained by hospital.

Event Description

Patient's right hip was revised.It was reported that: "pt.Presented with a pain and a non-union of a previous fracture that was treated with a gamma3 im nail.'the fracture is about a year old, the im nail is broken.We don¿t know if the non-union caused the nail to break or the nail broke causing the non-union.'" a gamma3 10x340x125 im nail with set screw, 10.5x80 lag screw, 5x35 distal screw, and 5x42.5 distal screw were explanted.Patient was revised to a hemi hip.

Manufacturer Narrative

Sections d and g4 were updated based on newly available product information.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was 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 affected device was not returned, and the lot number was not communicated.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 fracture was about a year old and it¿s not confirmed if the non-union caused nail breakage or the broken nail caused non-union.Considering past complaint history and this event, the probable root causes are (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

Patients right hip was revised.It was reported that: "pt.Presented with a pain and a non-union of a previous fracture that was treated with a gamma3 im nail.'the fracture is about a year old, the im nail is broken.We don¿t know if the non-union caused the nail to break or the nail broke causing the non-union.'" a gamma3 10x340x125 im nail with set screw, 10.5x80 lag screw, 5x35 distal screw, and 5x42.5 distal screw were explanted.Patient was revised to a hemi hip.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X340MM 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: 10774800
• MDR Text Key: 214355961
• Report Number: 0009610622-2020-00633
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K200869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 34250340S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR