MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE 12X440MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 2331-1244S

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Discomfort (2330)

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation any additional information will be communicated in a supplemental report.

Event Description

It was reported the patient had previous surgery (b)(6) 2021 for a left proximal femur fracture that was treated with a t2 alpha recon nail.After 3 months the nailed failed at the inferior recon screw hole.Patient told the surgeon that she had only been doing pt when she felt something uncomfortable in her left hip.X-ray confirmed that the implant had failed.On (b)(6) 2021 the broken t2 alpha recon nail was removed and revised with a synthes tfna.

Event Description

It was reported the patient had previous surgery (b)(6) 2021 for a left proximal femur fracture that was treated with a t2 alpha recon nail.After 3 months the nailed failed at the inferior recon screw hole.Patient told the surgeon that she had only been doing pt when she felt something uncomfortable in her left hip.X-ray confirmed that the implant had failed.On (b)(6)2 021 the broken t2 alpha recon nail was removed and revised with a synthes tfna.

Manufacturer Narrative

The reported event confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.Slight drill marks were found at the lateral entrance of the hole on the surface of the distal segment.However, more significant thing to note apart from the drill marks was the sign of overloading.Bearing points of lag screw at the medial edge of the proximal hole showed significant deformation, indicating towards high compressive load.The fracture pattern resembles a fatigue fracture, having equal portions of fatigue zone and instantaneous zone indicating that the breakage initiated in a fatigue manner but quickly broke instantaneously under high compressive loading.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: ¿adverse effects in many instances, adverse results may be clinically related rather than device related.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, osteomalicia, 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.Improper alignment can cause a mal-union of the bone and/or bending, cracking or even breakage of the device.¿ formal medical opinion was sought from an experienced independent medical expert as below: ¿in general, the surgical procedure looks well.The reposition of the bone looks well and there has been a cerclage to give support to the subtrochanteric communition zone.There are clear signs of non-union, pretty extensive callus formation and breakage of the nail.The age as well as the moderate overweight may have contributed a little to the failure.The main problem is the fracture pattern with the very instable subtrochanteric fracture with the communition zone.This kind of fracture is 100% dependent on the medical device to be stabilized.Even with some callus formation, there is almost no additional stability with the ingrowing connective tissue in the fracture gaps.Therefore, it takes a very long time to restore bone formation.In this case a gamma nail may have provided a little bit more stability, however, there is a good chance that failure may have occurred with it as well.From my perspective the failure is not related to the surgeon¿s technique or to the device, but to the highly instable fracture pattern and therefore patient related.¿ based on investigation, the root cause was attributed to a patient related issue.The failure was caused due to the highly instable fracture pattern.The age as well as the moderate overweight of the patient may have also contributed a little to the failure, but the main problem is the fracture pattern with the very instable subtrochanteric fracture with the communition zone.If any further information is provided, the complaint report will be updated.

• Brand Name: FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE 12X440MM
• 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: 12169625
• MDR Text Key: 265168161
• Report Number: 0009610622-2021-00596
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327284355
• UDI-Public: 07613327284355
• Combination Product (y/n): N
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Model Number: 2331-1244S
• Device Catalogue Number: 23311244S
• Device Lot Number: K093D71
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 09/26/2021
• Supplement Dates FDA Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 75