MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X300MM X 120; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3420-0300S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/28/2020
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: "on (b)(6) 2019, a patient underwent the initial operation due to subtrochanteric fracture of the femur.On (b)(6) 2020, she is scheduled to have revision surgery, because an atypical fracture caused by poor bone fusion and a nonunion occurred.The reporting sr was checking the progress to see if it would heal, but the bones did not heal and the nail broke." nail breakage due to nonunion.
Event or Problem Description
As reported: "on (b)(6) 2019, a patient underwent the initial operation due to subtrochanteric fracture of the femur.On (b)(6) 2020, she is scheduled to have revision surgery, because an atypical fracture caused by poor bone fusion and a nonunion occurred.The reporting sr was checking the progress to see if it would heal, but the bones did not heal and the nail broke." nail breakage due to nonunion.
Additional Manufacturer Narrative
Correction: refer to h6 results & conclusion codes.The reported event could be confirmed with the help of x-rays provided for investigation.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿the following are the most frequent adverse effects involving the use of internal fracture fixation devices: delayed union or non-union of the fracture site.These devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.Conditions attributable to non-union, osteoporosis, osteomalacia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone¿ formal medical opinion was sought from an experienced independent medical expert as below: ¿the gamma nail is indicated for subtrochanteric fractures.In this specific case the use of a t2 nail may have been considered, as it is easier to provide internal compression to the fracture.The atypical fractures occur with the use of bisphosphonates which are specifically for the treatment of osteopenia and osteoporosis-therefore it is very likely and these fractures come with problems in the healing as well.Age as a factor also contributes to a poor metabolism and therefore a poor healing tendency.As described in the case: non-union with non-optimal fracture compression as one contributing factor and thus nail breakage occurred.¿ based on investigation, the root cause was attributed to a patient factor related issue i.E.Non-union.As per the medical opinion, ¿patient¿s bone is osteoporotic/osteopenic.Age as a factor also contributes to a poor metabolism and therefore a poor healing tendency.¿ also, as per the medical opinion, in this specific case the use of a t2 nail may have been considered, as it is easier to provide internal compression to the fracture.Non-optimal fracture compression is also one of the contributing factors in this event.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X300MM X 120
• 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: 10743987
• Report Number: 0009610622-2020-00612
• Device Sequence Number: 3188584
• Product Code: HSB
• UDI-Device Identifier: 04546540375193
• UDI-Public: 04546540375193
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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 Expiration Date: 07/31/2021
• Device Model Number: 3420-0300S
• Device Catalogue Number: 34200300S
• Device Lot Number: K0B016C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 01/04/2021
• 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: 83 YR
• Patient Weight: 48